—#39614

Product

Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 4, 7.0 mm; Ref 1498-12-406.

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: Lots Y48D14, Y4RDM4, Y5GD84, Y5GD94, Y5GEA4 and Y5GEB4.

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 #39614. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.