—#39616

Product

Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 5, 9.5 mm; Ref 1498-12-508.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
510(k) numbers: K010810
Affected lot / code info: Lot XD8BK4.

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 #39616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.