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.

Catalog Number: 110010849 Lot Number Identification: 167880, 169620, 253190, 520810, 538490, 551550, 716270, 960180

Orthopedic Devices

1

No

FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI

Black Mamba Suture Passer

Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230

Orthopedic Devices

1

No

FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI

Green Mamba Suture Passer

50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254

Orthopedic Devices

1

No

Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.

High Flow Irrigation Extender; Part Number 72201021. || Arthroscopic accessories are indicated for use in access of the joint capsule.

BS535418105, BS535419118, BS535420030,  BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039,  BS535418127,  BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and  BS562325023.

Orthopedic Devices

1

No

Worldwide Distribution -- US, Spain, Italy, and Australia.

Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) || Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

Lot Codes: ( Devices within Expiry) 3009063 3009559 3010117 3010720 3011688 3012095 3012366 3014560 3016455 3018390 3020194 3022929 3025736 3027818 3030178 3032892 3036529 3071312 3071546 3074279 3074280 3076377 3076427 3085969 3089220 3093258 3098516 3101929 3104300 3107341 3111387 3114657 3115976 3119607 3123832 3124356 3124896 3125448 3128384

Orthopedic Devices

1

No

Worldwide distribution. US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.

Smith & Nephew BEAVER Blade 4.0mm || Part Number: 72203307 || Orthopedic surgical instrument used in hip arthroscopy.

Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514.  Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254

Orthopedic Devices

2

No

Distributed in Washington.

Reuseable rotary blade/abrader, product number 899751305. || The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

Affected lot 0207201502.

Orthopedic Devices

2

No

Distributed in Washington.

Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

Affected lot 4500166254.

Orthopedic Devices

2

No

Distributed in Washington.

Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.

Lot #144933, 14D252, and 14D253.

Orthopedic Devices

1

No

Nationwide Distribution

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France || Used to facilitate insertion of the Aero-AL cage into the disc space.

LOTS: SL15202 (150719822) 31-JUL-16 SL15203 (150719822) 31-JUL-16 SL15215 (150720063) 31-JUL-16 SL15216 (150720063) 31-JUL-16 SL15244 (150820583) 31-AUG-16 SL15246 (150820583) 31-AUG-16

Orthopedic Devices

1

No

Distributed only in Puerto Rico.

Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.