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Terminated

Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 3, 25.0 mm; Ref 96-2347.

FDA Recall Z-1325-05 · Posted 2005-08-12

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeNJL
Date Initiated2005-05-26
Date Terminated2005-12-02
Product Quantity9

Reason for Recall

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Root Cause

Other

Distribution Pattern

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Official Source

View FDA Recall →

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

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