Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684

Orthopedic Devices

2

Yes

Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.

Ceramic Femoral Head. || Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.

Cat. No. 545035500, Lot No. 7915797

Orthopedic Devices

2

Yes

Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.

SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.

Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026,  9124016, 9124027, 8918563

Orthopedic Devices

2

Yes

US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

M/N: VASECR35; Product Lot L4FF3W, Expiry Date 2017-11; Product Lot L4FF3X, Expiry Date 2017-11; Product Lot L4FF3Y, Expiry Date 2017-11; Product Lot M4H046, Expiry Date 2017-12; Product Lot M4H105, Expiry Date 2017-12; Product Lot M4H27D, Expiry Date 2017-12; Product Lot M4H30H, Expiry Date 2017-12; Product Lot M4H37J, Expiry Date 2017-12; Product Lot M4H399, Expiry Date 2017-12; Product Lot M4H589, Expiry Date 2018-01; Product Lot M4H54M, Expiry Date 2018-01; Product Lot M4H643, Expiry Date 2018-01 & Product Lot M4H691, Expiry Date 2018-01..

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.

ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, || Product Usage: || The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.

Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046

Orthopedic Devices

2

Yes

Nationwide Distribution

3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.

Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036

Orthopedic Devices

2

Yes

Nationwide Distribution.

DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.

Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution -- US (nationwide) and Canada.

Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. || Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.

Product Codes: 254500503, 254500504, 254500505, 254500506, 254500507, and 254500508. GTIN: 10603295132431, 10603295132448, 10603295132455, 10603295132462, 10603295132479, and 10603295132486.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes: 254500523, 254500524, 254500525, 254500526, 254500527, and 254500528. GTIN: 10603295132639, 10603295132646, 10603295132653, 10603295132660, 10603295132677, and 10603295132684.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes: 254500543, 254500544, 254500545, 254500546, 254500547, and 254500548. GTIN: 10603295132837, 10603295132844, 10603295132851, 10603295132868, 10603295132875, and 10603295132882.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes:254500981, 254500982, 254501989, and 254501990. GTIN: 10603295135586, 10603295135593, 10603295423492, and 10603295423959.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes: 254500563, 254500564, 254500565, 254500566, 254500567, and 254500568. GTIN: 10603295133032, 10603295133049, 10603295133056, 10603295133063, 10603295133070, and 10603295133087.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes:254500971, 254500972, 254500973, 254500974, 254500975, 254500976, 254500977, 254500978, 254500979, and 254500980. GTIN: 10603295135487, 10603295135494, 10603295135500, 10603295135517, 10603295135524, 10603295135531, 10603295135548, 10603295135555, 10603295135562, and 10603295135579.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes:254500991, 254500992, 254500993, 254500994, 254500995, 254500996, 254500997, 254500998, and 254500999. GTIN: 10603295135685, 10603295135692, 10603295135708, 10603295135715, 10603295135722, 10603295135739, 10603295135746, 10603295135753, and 10603295135760.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes:254501000 and GTIN: 10603295135777

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE CONV RP PS TB TRL SZ10 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes:254500961 and 254500962. GTIN: 10603295135388 and 10603295135395.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Product Codes:254501963, 254501964, 254501965, 254501966, 254501967, 254501968, 254501969, and 254501970. GTIN: 10603295423355, 10603295423362, 10603295423379, 10603295423386, 10603295423393, 10603295423409, 10603295423416, and 10603295423423.

Orthopedic Devices

2

Yes

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.

ATTUNE CONV FB CR TB TRL SZ3 - 10 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.

Part # 04.004.000, lot # 7950994

Orthopedic Devices

2

Yes

US Distribution to states of: MO and SC.

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

Part Number Lot Numbers 03.037.024 T102759

Orthopedic Devices

2

Yes

Nationwide Distribution.

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260

Dental Devices

2

Yes

Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.

Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.

Part Number: 03.501.080 Lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 8130898 8130975 8145793 8159386 8166417 8186954 8207769 8209190 8215969 8215999 8241958 8290959 8290968

Orthopedic Devices

2

Yes

Nationwide and internationally to Canada.

Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

All Lot Numbers of Part Numbers:  390.002 390.003 390.004 390.005 390.007 390.008 390.009 390.010 390.011 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 03.301.010S 03.301.011S 03.301.012S 03.301.013S 292.40 292.41 390.026 390.027 390.028 390.029 390.030 390.031 390.032 390.033 390.034 390.035 390.036 390.037 395.690 395.691 395.692 395.693 395.779 395.780 395.782 395.784 395.786 395.788 395.792 395.796 395.797 395.798 03.311.010 03.311.011 03.311.012 03.311.013 03.311.015 03.311.020 03.311.022 03.311.023 03.311.024 03.311.025 03.311.031 03.311.032 03.311.033 03.311.036 03.311.037 03.311.038 03.311.041 03.311.042 03.311.043 03.311.046 03.311.047 03.311.048 03.311.050 03.311.051 03.311.054 03.311.055 03.311.056 03.311.058 03.311.059 03.311.060 03.311.061 03.311.061.10 03.311.062 03.311.070 03.311.071 03.311.081 03.311.082 03.311.084 03.311.090 03.311.091 03.311.092 03.311.106 03.311.108 03.311.110 03.311.112 03.311.115 03.311.120 03.311.125 03.311.130 03.311.135 03.311.140 03.311.171 03.311.172 03.311.173 03.311.174 03.311.175 03.311.200 03.311.201 03.311.202 03.311.203 03.311.204 03.311.205 03.311.212 03.311.213 03.311.214 03.311.215 03.311.220 03.311.230 03.311.240 03.311.250 03.311.308 03.311.310 03.311.311 03.311.312 03.311.313 03.311.314 03.311.315 03.311.316 03.311.318 03.311.320 03.311.322 03.311.324 03.311.344 03.311.346 03.311.348 03.311.350 03.311.373 03.311.375 03.311.376 03.311.378 03.311.380 03.311.391 03.311.392 03.311.396 03.311.397 03.311.406 03.311.412 03.311.418 03.311.425 03.311.450 03.311.451 03.311.808 03.311.810 03.311.811 03.311.812 03.311.813 03.311.814 03.311.816 03.311.818 03.311.820 03.311.844 03.311.846 03.311.848 03.311.850 03.311.873 03.311.874 03.311.875 03.311.876 03.311.878 03.311.880 03.311.891 03.311.892 03.311.896 03.311.897 03.311.910 03.311.914 03.311.916 03.311.918 03.311.940 03.311.944 03.311.946 03.311.948 03.311.960 03.311.964 03.311.966 03.311.968 03.311.970 03.311.980 03.311.984 03.311.986 03.311.988 03.311.990 292.75 293.62 293.67 293.72 293.790 293.840 293.890 293.940 294.48 294.52 294.53 294.54 294.55 294.56 294.57 294.65 294.66 294.67 294.68 294.71 294.72 294.73 294.74 294.75 294.76 294.767 294.768 294.769 294.771 294.772 294.773 294.774 294.775 294.776 294.777 294.778 294.779 294.782 294.783 294.784 294.785 294.786 294.788 294.792 294.793 294.794 294.795 294.796 294.798 294.950 494.769 494.771 494.772 494.774 494.775 494.776 494.777 494.778 494.779 494.782 494.783 494.784 494.785 494.786 494.788 494.792 494.793 494.794 494.795 494.796 494.798 294.46SHA 294.52SHA 294.53SHA 294.54SHA 294.55SHA 294.56SHA 294.57SHA 294.67SHA 294.68SHA 294.73SHA 294.74SHA 294.75SHA 294.769SHA 294.76SHA 294.771SHA 294.772SHA 294.775SHA 294.776SHA 294.777SHA 294.778SHA 294.779SHA 294.782SHA 294.783SHA 294.784SHA 294.785SHA 294.786SHA 294.788SHA 294.792SHA 294.793SHA 294.794SHA 294.795SHA 294.796SHA 294.798SHA 494.771SHA 494.772SHA 494.775SHA 494.776SHA 494.777SHA 494.778SHA 494.779SHA 494.782SHA 494.783SHA 494.784SHA 494.785SHA 494.786SHA 494.788SHA 390.041 390.042 395.60 395.61 395.63 395.64 395.65 395.680 395.681 395.682 395.685 395.686 395.687 395.688 390.006 390.012 690.315 390.051 394.055 690.451 03.390.052S 03.390.053S 03.390.054S 03.390.055S 03.390.056S 03.390.057S SD311.202 SD311.203 SD311.204 SD311.205 SD357.100 293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48 293.49 293.50 293.51 293.52 293.53 293.54 293.58 293.59 293.63 293.68 293.69 293.73 293.74 293.78 293.83 293.88 293.93 294.30 294.43 294.44 294.45 294.455 294.46 293.48L 293.48X 294.30SHA 294.43SHA 294.44SHA 294.45SHA 395.62 395.66 395.67 690.978 03.304.220S 03.304.222S 03.304.320S 03.304.322S

Orthopedic Devices

2

Yes

Worldwide Distribution-including US (nationwide) and Canada.

Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

Part Number 329.315 460.001 460.001.01S 460.002 460.002.01S 460.003 460.003.01S 460.008 460.008.01S 460.009 460.009.01S 460.010 460.010.01S 460.100 460.100.01S 460.107 460.107.01S with Lot Numbers 4146716, 4154144, 4206682, 4206683, 4213557, 4214824, 4216603, 4216604, 4240689, 4240690, 4241741, 4248462, 4249395, 4249396, 4264386, 4278302, 4278304, 4283035, 4283036, 4283037, 4283038, 4283039, 4283040, 4283041, 4285956, 4289103, 4295084, 4295085, 4298044, 4303093, 4326975, 4326979, 4326981, 4329355, 4331263, 4331265, 4331266, 4344659, 4344678, 4378973, 4482201, 4485317, 4488093, 4488094, 4490608, 4490609, 4496716, 4496915, 4496916, 4501971, 4504043, 4508068, 4513458, 4513459, 4513460, 4513461, 4516371, 4519406, 4519407, 4521408, 4525905, 4550062, 4550063, 4550064, 4550065, 4551164, 4551165, 4551166, 4561400, 4561401, 4572176, 4574481, 4580884, 4586704, 4605094, 4661414, 4669482, 4669483, 4675725, 4695343, 4705970, 4723148, 4753792, 4753794, 4777999, 4778000, 4906228, 4906229, 4914498, 4917681, 4934562, 4944809, 4956361, 4956363, 4983255, 4983256, 4983257, 5007806, 5041856, 5041857, 5041858, 5046857, 5046859, 5098159, 5113496, 5113497, 5134868, 5134869, 5143883, 5204105, 5230669, 5234395, 5234396, 5245233, 5245237, 5251710, 5292433, 5308690, 5308733, 5341509, 5370371, 5370375, 5438364, 5452452, 5465222, 5655435, 5667092, 5697537, 5726966, 5726967, 5726968, 5726969, 5726970, 5726971, 5801281, 5801284, 5801285, 5801287, 6036379, 6036381, 6168066, 6188888, 6188890, 6268389, 6268390, 6272370, 6322541, 6364587, 6553805, 6861415, 6983782, 7032568, 7505227, 7640627

Neurological Devices

2

Yes

US Nationwide and internationally, including Canada.

Synthes Cranial Flap Tube Clamp and Crimping Device || Product Usage: || The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm

Orthopedic Devices

2

Yes

Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada.

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Part Number Lot Number 04.037.162S 7950511

Orthopedic Devices

2

Yes

US Distribution to states of: CA, FL, MI and WI.

Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.