TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
Hazard
Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
What You Should Do
Remedy
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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Products
TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
- Brand
- Plus Orthopedics
- UPC
- Lot 0006.13.2635
Units Affected
5