FDA Device

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.

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