TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
This recall has been terminated (originally issued November 27, 2003).
- Company
- Plus Orthopedics
- Recall Initiated
- September 9, 2002
- Posted
- November 27, 2003
- Terminated
- December 30, 2003
- Recall Number
- Z-0170-04
- Quantity
- 5
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
Distribution
TX,
Lot / Code Info
Lot 0006.13.2635
Root Cause
Other
Action Taken
Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
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