Device Recall Stryker Howmedica Osteonics

ER5ND5 ER6EG4 ER5NE4 ER6EG5 ER5NE4M ER6EG5A ER6CG9 ER6KA1 ER6CG9A ER6KA2 ER6CH1 ER6KA3 ER6CH1A ER6KA3A ER6CH1D ER6KA3T ER6CH1M ER6KA4 ER6ED1 ER6KA5 ER6ED1A ER6KA6 ER6ED2 ER6KA7 ER6ED3 ER6KA7T ER6ED4 ER6KA8 ER6ED5 ER6KA8T ER6ED6 ER6KA9 ER6ED7 ER6KD1 ER6ED7E ER6KD2 ER6ED8 ER6KD3 ER6ED8J ER6KD4 ER6ED9 ER6KD5 ER6EE1Y ER6KD6 ER6EE2 ER6KD7 ER6EE6 ER6MA3 ER6EE6M ER6MA4 ER6EE7 ER6SA3 ER6EE7J ER6SA3J ER6EF2 ER6SA3X ER6EF3 ER6SA4 ER6EF3A ER7MA3 ER6EF4 ER7MA3D ER6EF4M ER7MA3M ER6EF5 ER7MA3T ER6EF6 ER7MA4 ER6EF6P ER7MA4A ER6EF8 ER7MA4E ER6EF9 ER7MA4T ER6EG2 ER8SK2 ER6EG3 ER8SK2M    ER8SK2P ER8SK3 ER8SK3X ER8SK4 ER8SK4A ER8SK4T ER8WA6 ER8WA6P ER8WA6X ER8WA9 ER8WA9A ER8WA9P ER9CH0 ER9CH0A ER9EA7

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.

Triathlon Distal Capture Assembly || Catalog No: 6541-1-723 || The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).

510K exempt Catalog Number 1020-1400 Lot Code P5E93

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Stryker Howmedica Osteonics Accolade Offset Rasp Handle || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France || Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.

Class I, 510(k) exempt  Catalog Number: 6543-1-600  Lot Number; NE1WR1

Orthopedic Devices

1

No

Worldwide Distribution.

Stryker Orthopaedics || FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS || REF 6543-1-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. || Made in USA

Class I, 510(k) exempt  Catalog Number: 6543-2-600  Lot Number: P1S43, P2A31

Orthopedic Devices

1

No

Worldwide Distribution.

Stryker Orthopaedics || TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS || REF 6543-2-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || Made in USA || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.

Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306

Orthopedic Devices

1

No

Nationwide Distribution.

Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100