Part #'s 900728 900737 900738 900740 909836 110008343 110009769 231201303  Lot #'s 669220 625160 625180 679060 529190 585920 742460 751280 751290 751330 751400 751410 751420 751430 630570

Orthopedic Devices

1

No

Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Various trauma and sports medicine instruments and implants. || Orthopedic manual surgical instrument.

Part #'s 24445 27961 904301 904760 231201307  Lot #'s 693880 606180 614250 668360 625470 710630 710640 668330

Orthopedic Devices

1

No

Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Various trauma and sports medicine instruments and implants. || Bit, drill.

Part #'s 904051  Lot #'s 880370 673790

Orthopedic Devices

1

No

Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.

Various trauma and sports medicine instruments and implants. || Passer.

Lots 095112 and 474660.

Orthopedic Devices

1

No

Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.

Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Biomet Orthopedics, Inc., Warsaw, IN. 46581

Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720

Orthopedic Devices

1

No

AL, MO and UT Canada, Australia, Netherlands, and Egypt

Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

All units including lots 429900, 642100 and 647700.

Orthopedic Devices

1

No

Worldwide: USA, Canada and Japan.

Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN

All units.. including lots 105300, 007602, 011900, 014300, 014900, 103500, 209700, 219100, 232000, 306900, 331600, 520800, 526200, 610000, 619600, 644100, 007600, 007601, 007603, 007604, 011900, 014300, 014900, 014901, 020700, 024100, 103500, 105300, 109004, 123100, 206100, 209700, 219100, 228600, 229200, 232000, 306900, 307000, 317200, 322800, 331600, 403800, 406800, 411200, 411300, 413100, 415000, 418200, 421100, 423900, 429200, 432300, 437300, 443200, 503700, 506800, 511200, 520800, 526200, 545200, 552000, 555700, 555870, 600200, 606900, 610000, 610600, 624140, 626500, 630800, 644100, 645700, 645800, 708600, 708700 and 999999.

Orthopedic Devices

1

No

Worldwide: USA, Canada and Japan.

Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

Lot Number: 607452.

Orthopedic Devices

1

No

Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.

Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. || Vacuum mixing and vacuum collection system and application system for bone cement.

Lot Numbers 540199, 540199-1

Orthopedic Devices

1

No

Nationwide Distribution, including the states of MO, TX, and IN.

Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Part numbers: 406993, Lot numbers:176070 and 657550; and 406993-00, Lot number : 203119.

Orthopedic Devices

1

No

International Distribution Only: Canada, Australia, and Columbia.

Comprehensive Reverse Humeral Fracture Inserter || REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. || Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.

Lot Number: 038700.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038730.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038670.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038680.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038690.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038710.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.

Device listing # D090878 Catalog # LV00407 Lot #184090

Orthopedic Devices

1

No

US Distribution to CA

Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 || The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

Catalog ID 03.010.100S Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051 5575918, 6199232, 6676406, 5603463, 6231850, 6721724 5649117, 6256560, 6734876, 5668880, 6305842, 6808463 5724639, 6319050, 6831468, 5742276, 6320150, 6997294 5807341, 6343980, 7039877, 6012770, 6401819, 7052565 6045597, 6448707, 7081479, 6057914, 6472100, 7378832 6108342, 6501856, 7410311, 6142443, 6503351, 7466207 7554670, 7620971, 7675571, 7711694, 7801251, 7918026 9815103, 9828932, 9905850, 9939769, H033348

Orthopedic Devices

1

No

US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI

3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile || Product Usage: || The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

Catalog ID 03.010.060S Lot # 5558809, 6204324, 6813586, 7648837, 5559839, 6214366, 6818438, 7648838, 5575915, 6235676, 6827807, 7657752, 5579717, 6240287, 6830470, 7657753, 5582298, 6247514, 6835634, 7660380, 5585788, 6249834, 6841962, 7661528 5594237, 6269336, 6851101, 7661529, 5594238, 6276953, 6857546, 7674414, 5616439, 6279756, 6860704, 7687319, 5633067, 6279757, 6870563, 7693164, 5656914, 6302746, 6873394, 7716604, 5672506, 6313568, 6873396, 7731690 5682043, 6313569, 6898040, 7739027, 5692087, 6325420, 6904377, 7753584, 5702206, 6331923, 6908328, 7766654, 5711966, 6334954, 6919278, 7774127, 5724637, 6339936, 6925232, 7774128, 5727691, 6348925, 6931055, 7794479 5732158, 6355191, 6939080, 7817283, 5741332, 6368986, 6949503, 7830606, 5748361, 6375334, 6961056, 7835732, 5760640, 6382329, 6967764, 7848333, 5772367, 6398746, 6975982, 7869029, 5780654, 6413506, 6984973, 7870629 5782800, 6420887, 6996252, 7894923, 5782801, 6433683, 7004816, 7899079, 5782802, 6433684, 7013143, 7903010, 5794181, 6438144, 7019693, 7908522, 5816780, 6449832, 7029024, 7918012, 5818769, 6458079, 7036198, 7919639 5818770, 6464443, 7052563, 7924989, 5829138, 6475737, 7064072, 7941743, 5847359, 6480417, 7070681, 7947278, 5860702, 6486376, 7084937, 7963626, 5861834, 6488940, 7275546, 7981633, 5861836, 6505811, 7304754, 7993351 5870708, 6509276, 7349355, 9808655, 6010554, 6528479, 7359254, 9820617, 6031951, 6540263, 7371663, 9825386, 6034093, 6549146, 7382623, 9826363, 6034128, 6557658, 7400014, 9831036, 6051790, 6563112, 7400015, 9841499 6052762, 6572199, 7400016, 9855040, 6055036, 6577880, 7416878, 9859105, 6066429, 6586607, 7422660, 9864677, 6069150, 6593553, 7441691, 9869742, 6069151, 6598206, 7444103, 9878216, 6074684, 6603184, 7460590, 9886333 6080184, 6610704, 7465210, 9904888, 6081960, 6621162, 7476937, 9911126, 6091446, 6636693, 7485616, 9915461, 6092777, 6655352, 7497778, 9924572, 6109266, 6674053, 7499940, 9932287, 6121870, 6686555, 7512119, 9939768 6124816, 6707678, 7520264, 9959608, 6130838, 6721722, 7533286, 9961574, 6133623, 6733633, 7544212, 9970453, 6136836, 6752258, 7554690, 9985425, 6141455, 6761019, 7563621, H023093, 6153365, 6766654, 7636777, H024812 6163583, 6777654, 7636778, H034525, 6186051, 6786129, 7636779, H039109, 6186052, 6796018, 7648835, 6187891, 6796019, 7648836

Orthopedic Devices

1

No

US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI

3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S || Product Usage: Usage: || The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

Catalog Number: 110010849  Lot Number: 169620, 253190

Orthopedic Devices

1

No

Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.

Black Mamba Suture Passer. || The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.

All product shipped prior to 09/27/2016;  DFU 18-0040; Part No. BLACKMAX-N-LP

Orthopedic Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

BLACKMAX-NEURO LOW PRESSURE || Product Usage: || Pneumatic system

Part Number: 900738 Lot Number (LN): 889990

Orthopedic Devices

1

No

No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

Bone Dowell Harvest Tubes

Orthopedic Devices

Lot numbers 140312026 140412702 140513380 140513481 140714306 140814551 140814961

Orthopedic Devices

1

No

US Distribution to Florida, New York and Puerto Rico..

Carpal Tunnel Surgical Large Pack, Catalog # 900-742A || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and/or bone fragments)CLAW 3.5MM PLATE 2 HOLE 30MM (40130130);CLAW PLATE 20MM INTERAXIS (40S20020);CLAW II 2 HOLE 15MM (40240215), 20MM (40240220), 25MM (40240225), 30MM (40240230);CLAW II STRAIGHT20 X 20MM (40242020), 20 X 25MM (40242025), 25 X 25MM (40242525). (Catalog Numbers in brackets)Multiple lot numbers affectedARTG Number: 198485

Orthopedic Devices