Recall Z-1030-05 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Depuy Orthopaedics, Inc.
Depuy brand LCS Complete metal backed patella, cemented, LRG; REF 1294-09-760.
| Date | Jul 21, 2005 (initiated Jun 7, 2005) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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. |
| Distribution | Nationwide and international. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.