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Terminated

TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.

FDA Recall Z-0126-06 · Posted 2005-11-03

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-02-22
Date Terminated2007-02-05
Product Quantity1 unit

Reason for Recall

Labeling discrepancy.

Firm Action

Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.

Root Cause

Other

Distribution Pattern

NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000666TC-PLUS SOLUTION KNEEPlus Orthopedics · 2000-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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