TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
FDA Recall Z-0170-04 · Posted 2003-11-27
Recalling FirmPlus Orthopedics
Recall StatusTerminated
Product CodeJWH
Date Initiated2002-09-09
Date Terminated2003-12-30
Product Quantity5
Reason for Recall
Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
Firm Action
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
Distribution Pattern
TX,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.