TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
FDA device recall Z-0170-04 · posted 2003-11-27 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics
- Reason for recall
- Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 5
- Distribution
- TX,
- Date initiated
- 2002-09-09
- Date posted
- 2003-11-27
- Date terminated
- 2003-12-30
- Location
- San Diego, CA
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