Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia, Sz 3, 15.0 mm; Ref 96-2643.
FDA device recall Z-1285-05 · posted 2005-08-12 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- 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
- Status
- Terminated
- Product code
- NJL
- Quantity affected
- 10
- Distribution
- Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
- Date initiated
- 2005-05-26
- Date posted
- 2005-08-12
- Date terminated
- 2005-12-02
- Location
- Warsaw, IN
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