Code:9002616 Lots: 141015729 exp. 10/31/15 141216309 exp. 12/31/15 150116557 exp. 2/28/16 150317941 exp. 3/31/16 150317942 exp. 3/31/16 150317943 exp. 4/30/16 150418380 exp. 5/31/16 150317945 exp. 5/31/16 150317944 exp. 5/31/16 150418381 exp. 5/31/16 150418379 exp. 5/31/16 150317946 exp. 6/30/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

SHOULDER PACK 6/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002719 Lots: 140915486 exp. 4/30/16 150116570 exp. 1/31/16 150116569 exp. 1/31/16 150116568 exp. 3/31/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

SHOULDER ARTHROSCOPY PACK 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002726 Lots: 141015706 exp. 10/31/15 141216325 exp. 12/31/15 150116528 exp. 1/31/16 150117019 exp. 2/28/16 150117019 exp. 2/28/16 150317948 exp. 5/31/16 150317949 exp. 5/31/16 150518787 exp. 5/31/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

REEMPLAZO DE RODILLA Y CADERA 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002766 Lots: 141015730 exp. 10/31/15 141015730 exp. 10/31/15 140915329 exp. 10/31/15 141216293 exp. 12/31/15 150116517 exp. 1/31/16 150317647 exp. 3/31/16 150418382 exp. 5/31/16 150418382 exp. 5/31/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

SHOULDER PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9002830 Lots: 141015715 exp. 10/31/15 140915331 exp. 12/31/15 141216445 exp. 12/31/15

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

ORTHOPEDIC PACK BASIC 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900620 Lots: 141015723 exp. 10/31/16 141015723 exp. 10/31/16 141216354 exp. 12/31/15 150217428 exp. 11/30/15 150217427 exp. 11/30/15 150317653 exp. 4/30/16

Orthopedic Devices

2

No

Distributed Only in Puerto Rico.

ARTHROSCOPY PK 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900740A Lots: 140915497 exp. 1/31/16 141216360 exp. 12/31/15 141216449 exp. 1/31/16 141216449 exp. 1/31/16 150317655 exp. 3/31/16 150317656 exp. 3/31/16 150318093 exp. 3/31/16 150418420 exp. 4/30/16 150518838 exp. 5/31/16 150619188 exp. 6/30/16 150619405 exp. 6/30/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

ARTHROSCOPY SURGICAL PACK 4/C || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900741A Lots: 140915516 exp. 11/30/15 150116509 exp. 12/31/15 150116510 exp. 12/31/15 150317657 exp. 3/31/16 150318094 exp. 3/31/16 150318095 exp. 3/31/16 150318197 exp. 4/30/16 150318196 exp. 4/30/16 150318198 exp. 4/30/15 150518839 exp. 5/31/16 150619189 exp. 6/30/16 150619406 exp. 6/30/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

ORTHO-IMPLANT SURGICAL PACK, || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900742A Lots: 141015498 exp. 1/31/16 141216361 exp. 12/31/15 150116507 exp. 12/31/15 141216450 exp. 1/31/16 150317875 exp. 3/31/16 150317876 exp. 3/31/16 150418421 exp. 4/30/16 150518841 exp. 5/31/16 150619190 exp. 6/30/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

CARPAL TUNEL LARGE SURGICAL PACK, 6/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:900902 Lots: 141015741 exp. 10/31/15 141015741 exp. 10/31/15 150518846 exp. 5/31/16

Orthopedic Devices

2

No

Distributed Only in Puerto Rico.

ARTHROSCOPY PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Lot 1363-01

Orthopedic Devices

1

No

Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.

3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System || The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708

Orthopedic Devices

1

No

Nationwide throughout the US

Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.

Code: 900982 Lots: 141015603 exp. 10/31/15 141216365 exp. 12/31/15 150116540 exp. 1/31/16 150116982 exp. 1/31/16 150418429 exp. 5/31/16 150317871 exp. 5/31/16 150518850 exp. 6/30/16

Orthopedic Devices

1

No

Distributed Only in Puerto Rico.

ARTHROSCOPY PK L/F 5/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Orthopedic Devices

1

No

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Serial Numbers (US):  0355239 0355108 0355474 0354538 Serial Numbers (OUS):  0353919 0354845 0354849

Orthopedic Devices

2

No

Distributed Nationwide and in Germany, Switzerland, and UK.

ConForMIS iUni Unicondylar Knee Replacement System: || iUNI G2, Left Lateral || Catalog Number: M57220600230 (US) || M5722INT0600230 (OUS)

Serial Numbers (US): 0353901 0354506 0354220 0355550 0355016 0350789 0354111 0354321 0352939 0353154 0353812 0354828 0354576 0354180 0355588 0355064 0353912 0351237 0351983 0354434 0353374 0351642 0352751 0355557 0353757 0353944 0354218 0353846 0353688 0355110 0352483 0345608 0353771 0353306 3054517 Serial Numbers (OUS): 0348705 0349592 0351522 0351616 0352700 0352750 0352827 0352840 0352999 0353210 0353225 0353263 0353420 0353514 0353515 0353577 0353714 0353791 0353822 0353918 0353921 0354163 0354208 0354284 0354292 0354439 0354507 0354509 0354605 0354771 0354773 0354792 0355178 0355188 0355202 0355227

Orthopedic Devices

2

No

Distributed Nationwide and in Germany, Switzerland, and UK.

ConForMIS Unicondylar Knee Replacement System || iUNI G2, Left Medial || Catalog Number: M57220600210(US) || M5722INT0600210 (OUS)

Serial Numbers (US):  0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233

Orthopedic Devices

2

No

Distributed Nationwide and in Germany, Switzerland, and UK.

ConForMIS iUNI Unicondylar Knee Replacement System || iUNI G2, Right Lateral || Catalog Number: M57220600240 (US) || M5722INT0600240 (OUS)

Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.

Orthopedic Devices

2

No

Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.

Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.

Lot Number: M1505055

Orthopedic Devices

2

No

Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.

FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 || Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Lot Number: M1505053

Orthopedic Devices

2

No

Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.

FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 || Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Lot Number: M1505056

Orthopedic Devices

2

No

Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.

FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 || Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598.

Orthopedic Devices

1

No

Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.

Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.

Distal Rod Item Number 42-5399-002-00 Lots: 62137112, 62156914, 62222599.

Orthopedic Devices

1

No

Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.

Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.

Lot number MDHZ620

Orthopedic Devices

2

No

US distribution to the states: TX, UT, NY and CO.

Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.

Part number: 352.135;  Lot number: F-17180

Orthopedic Devices

1

No

US nationwide distibution.

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.