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Terminated

Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 2, 7.0 mm; Ref 1498-12-206.

FDA Recall Z-1147-05 · Posted 2005-08-12

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeNJL
Date Initiated2005-05-26
Date Terminated2005-12-02
Product Quantity96

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010810DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESISDePuy Orthopaedics, Inc. · 2001-04-18

Official Source

View FDA Recall →

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

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