—#39543

Product

Depuy brand LCS Complete metal backed patella, porocoat, STD+; REF 1294-09-650.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P830055/R44
Affected lot / code info: Lots 1829091, 1831724, 1834697, 1834698, 1837368, 1840605, 1840609, 1851643, 1859876, 1859879 and 1862192.

Why it was recalled

There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.

Root cause (FDA determination)

Other

Action the firm took

Hospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide and international.

Timeline

Recall initiated: 2005-06-07
Posted by FDA: 2005-07-21
Terminated: 2006-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.