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Terminated

Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031.

FDA Recall Z-1332-05 · Posted 2005-08-12

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-05-26
Date Terminated2005-12-02
Product Quantity5

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.

K884796P.F.C.(TM) MODULAR KNEE SYSTEMJohnson & Johnson Professionals, Inc. · 1989-03-29

Official Source

View FDA Recall →

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

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