Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

Catalog Number: 690110 Lot Numbers: 128, 214

Orthopedic Devices

1

No

CT, OH, FL, OK, TX, RI, NV, SC,

Apex Pilot Shaft, 10mm

Catalog Number: 69011 Lot Numbers: 052, 113, 214

Orthopedic Devices

1

No

CT, OH, FL, OK, TX, RI, NV, SC,

Apex Pilot Shaft, 11.5mm

Catalog Number: 690113 Lot NUmbers: 052, 113, 214

Orthopedic Devices

1

No

CT, OH, FL, OK, TX, RI, NV, SC,

Apex Pilot Shaft 13mm

Catalog Number: 690114 Lot NUmbers: 052, 113, 214

Orthopedic Devices

1

No

CT, OH, FL, OK, TX, RI, NV, SC,

Apex Pilot Shaft 14.4mm

Catalog Number: 690116 Lot NUmbers: 052, 113, 214

Orthopedic Devices

1

No

CT, OH, FL, OK, TX, RI, NV, SC,

Apex Pilot Shaft 16mm

Catalog Number: 690117 Lot NUmbers: 052, 113, 214

Orthopedic Devices

1

No

CT, OH, FL, OK, TX, RI, NV, SC,

Apex Pilot Shaft 17.5mm

Application Instrument for Sternal ZipFixPart Number: 03.501.080Lot Number: All 1st generation Application Instruments - Lots prior to 8100630ARTG Number: 153950

Orthopedic Devices

Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion)Product Number: 03.501.080 Multiple Lot Numbers (see attached)ARTG Number: 153950

Orthopedic Devices

Orthopedic Devices

Orthopedic Devices

md

Ardis Inserter (intended for delivery of the Ardis interbody spacer into the prepared disc space)Part Number: 3256-01ARTG Number: 157926

Orthopedic Devices

Orthopedic Devices

Medical instruments for use in humans

Orthopedic Devices

Orthopedic Devices

Instrument - reusable

Lot numbers 140613947

Orthopedic Devices

1

No

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

Arthroscopy Pack, Catalog number 900-1832. || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Lot numbers 140513400

Orthopedic Devices

1

No

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

Arthroscopy Pack, catalog #900-2473 || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Brochure intended for international distribution, Document: LC-04-107-011

Orthopedic Devices

AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, VA, SC, MD, MA, CT, VT, ME, ID, LA, WI, NE

Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal

Removal domestically of literature Document: LC-04-207-001

Orthopedic Devices

AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE

Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. || The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005

AVS ARIA Implant InserterItem number: 48758500 (Located in Instrument Tray 48759040-T)Lots numbers affected: 107400, 10G906, 110214ARTG number: 178870

Orthopedic Devices

Lot number: 2000930

Orthopedic Devices

1

No

Distributed in the state of Massachusetts

Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.

12 MM Screw Distraction with Product Code: S-0088 and etched with Manufacturing lot number and date:   G11 07/25/2011, J11 10/27/2011, D12 04/24/2012, D12 04/24/2012, F12 06/06/2012, K12 11/06/2012, K12 11/06/2012, L12 12/12/2012, F13 06/20/2013, H13 08/26/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01/22/2014, C14 03/06/2014, D14 04/24/2014, G14 07/31/2014, I14 09/03/2014, L14 12/16/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, H15 08/11 /2015, I15 09/23/2015, K15 11/18/2015, A16 01/06/2016, B16 02/15/2016, C16 03/08/2016, D16 04/21/2016, E16 05/18/2016 and F16 06/14/2016.   Contained in sterile packages with the following packaging lot numbers and date:  979662 01/07/2011, 985463 03/08/2011, 009375 06/23/2011, 043419 10/21/2011, 064776 02/03/2012, 102167 09/11/2012, 110798 09/25/2012, 127811 12/11/2012, 859648 01/09/2014, 859649 01/09/2014, 859650 01/09/2014, 859651 01/09/2014, 862414 04/23/2014, 862415 04/23/2014, 862416 04/23/2014, 862417 04/23/2014, 862418 04/23/2014, 862419 04/23/2014, 862420 04/23/2014, 868984 02/16/2015, 868985 02/16/2015, 868986 02/16/2015, 873620 08/11/2015, 873621 08/11/2015, 873622 08/11/2015, 873623 08/11/2015, 876504 12/14/2015, 876505 12/14/2015, 876506 12/14/2015, 879271 04/04/2016, 879272 04/04/2016, 881178 06/10/2016, 881179 06/10/2016 and 881180 06/10/2016.   14MM Screw Distraction with Product Code: S-0089 and etched with Manufacturing lot number and date:   E11 05/25/2011, G11 07/28/2011, J11 10/27/2011, C12 03/27/2012, F12 06/12/2012, G12 07/26/2012, I12 09/19/2012, I12 09/19/2012, J12 10/09/2012, J12 10/31/2012, L12 12/03/2012, L12 12/07/2012, A13 01/08/2013, G13 07/19/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01 /22/2014, 014 04/24/2014 I, F14 06/16/2014, F14 06/16/2014, C14 03/06/2014, G14 07/24/2014, I14 09/03/2014, J14 10/17/2014, L14 12/1 6/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, F15 06/02/2015, G15 07/16/2015, I15 09/15/2015, K15 11/18/2015, A16 01/06/2016, 816 02/15/2016, B16 02/15/2016, C16 03/08/2016 and D16 04/21/2016.  Contained in sterile packages with the following packaging lot numbers and date:  009413 06/22/2011, 038155 10/11/2011, 064187 02/03/2012, 098560 07/12/2012, 100104 07/24/2012, 127814 12/11/2012, 859626 01/09/2014, 859627 01/09/2014, 859645 01/09/2014, 859646 01/09/2014, 859647 01/09/2014, 862172 04/23/2014, 862173 04/23/2014, 862174 04/23/2014, 862194 04/23/2014, 862195 04/23/2014, 862196 04/23/2014, 862197 04/23/2014, 862198 04/23/2014, 862199 04/23/2014, 865271 09/23/2014, 865300 09/23/2014, 865301 09/23/2014, 865302 09/23/2014, 865303 09/23/2014, 865351 09/23/2014, 868947 02/16/2015, 868948 02/16/2015, 868949 02/16/2015, 868950 02/16/2015, 872970 08/05/2015, 872971 08/05/2015, 872972 08/05/2015, 872973 08/05/2015, 873669 08/11/2015, 873670 08/11/2015, 873671 08/11/2015, 876472 12/14/2015, 876473 12/14/2015, 876474 12/14/2015 I, 879298 04/04/2016, 879299 04/04/2016, 881174 06/10/2016, 881175 06/10/2016, 881176 06/10/2016, 881177 06/10/2016 and 985679 03/08/2011.  16 MM Screw Distraction with Product Code: S-0090 and etched with Manufacturing lot number and date:   Al2 1/20/2012, C12 3/27/2012, A13 1/10/2013, J13 10/3/2013 and G14 7/24/2014.  Contained in sterile packages with the following packaging lot numbers and date:  003923 05/12/2011, 098394 07/13/2012, 854634 04/1 9/2013, 854635 04/1 9/2013, 854636 04/19/2013 and 862500 04/23/2013.   18 MM Screw Distraction with Product Code: S-009 and etched with Manufacturing lot number and date:   A12 1/16/2012 and F12 6/12/2012.   Contained in sterile packages with the following packaging lot numbers and date:  120328 10/9/2012, 133021 12/20/2012 and 133021 12/20/2012.

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.

V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

Lot 027410.

Orthopedic Devices

1

No

Nationwide Distribution -- Including the state of Texas.

Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.

Part #'s 908518 908520  Lot #'s 675890 579290 579300

Orthopedic Devices

2

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. || Arthroscope.

Part #'s 41009 110004188 110010579  Lot #'s 668490 756990 757010 757030 758180

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. || Reamer.