Recalls / —
—#39703
Product
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 4, 30.0 mm; Ref 96-0547.
- FDA product code
- NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P830055S084
- Affected lot / code info
- Lot 86493A.
Why it was recalled
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 (FDA determination)
Other
Recalling firm
- Firm
- Depuy Orthopaedics, Inc.
- Address
- 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994
Distribution
- Distribution pattern
- Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
Timeline
- Recall initiated
- 2005-05-26
- Posted by FDA
- 2005-08-12
- Terminated
- 2005-12-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #39703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.