Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 22.5 mm; Ref 1581-24-022.
FDA Recall Z-1189-05 · Posted 2005-08-12
Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-05-26
Date Terminated2005-12-02
Product Quantity12
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.