—#39582

Product

Depuy LCS Complete RP insert; polyethylene tibial insert STD, 10 mm; Ref 1294-05-410.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P830055S074
Affected lot / code info: Lots X1KCA4, X1KCR4, X1TBK4, X3BCL4, X3BCM4, X3KCD4, X3KCL4, X3KCP4, X3KCT4, X66BJ4, X74GH4, X82EL4, Y15A64, Y18BR4, Y18BS4, Y18BT4, Y18CA4, Y18CC4, Y2TDR4, Y3EGD4, Y3EGF4, Y3EGN4, Y41H84, Y41HY4, Y4XC54, Y4XCR4, Y4XDE4, Y4XDF4, Y4XDJ4, Y51F34, Y51F44, Y51F64, Y51F84, Y6DG74, Y6DHD4, Y75KY4, YA8EV4, YA8FF4, YD7C24, YD7C64, YD7CY4, YE7BD4, YE7BH4, YE7BK4 and YJ5B84.

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 #39582. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.