Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
This recall has been terminated (originally issued December 22, 2009).
- Company
- Zimmer Inc.
- Recall Initiated
- February 26, 2009
- Posted
- December 22, 2009
- Terminated
- February 28, 2011
- Recall Number
- Z-0555-2010
- Quantity
- 13
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Smaller diameter screws than required were included in the package.
Distribution
USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.
Lot / Code Info
Lot 07878240.
Root Cause
Process control
Action Taken
Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
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