FDA Recall
Terminated
MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
Recall: Z-0539-05
·
Initiated December 17, 2004
Recall
- Recall Number
- Z-0539-05
- Event Number
- 30720
- Firm
- Zimmer Austin, Inc
- FEI Number
- 2935620
- Product Code
- KRO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 17, 2004
- Posted
- February 15, 2005
- Terminated
- November 27, 2007
- Address
- 9900 Spectrum Dr, Austin, TX, 78717-4555
Description
MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
Reason
Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
Action
The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.
Distribution
The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal
Quantity
121 units