Z-1024-05

Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640

Name: Z-1024-05 Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640
Creator: Depuy Orthopaedics, Inc.
Published: 2005-06-07
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2005-06-07 / Terminated / root cause: manufacturing process

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640 on 2005-06-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1024-05
Status: Terminated
Initiated: 2005-06-07
Posted: 2005-07-21
Terminated: 2006-05-02
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: 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 tag: manufacturing process
FDA 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.
Product codes and lots: Lots 1831720, 1831721, 1837366, 1837367, 1840603, 1845651 and 1855830.

Product code NJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)