Z-0057-2007

Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100

Name: Z-0057-2007 Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100
Creator: Depuy Orthopaedics, Inc.
Published: 2006-09-14
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2006-09-14 / Terminated / root cause: labeling and UDI

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100 on 2006-09-14. The reason FDA records is "Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0057-2007
Status: Terminated
Initiated: 2006-09-14
Posted: 2006-10-21
Terminated: 2007-04-26
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product.
Quantity in commerce: 9
Distribution: Nationwide.
Product codes and lots: Lot 2203528.

Product code JWH

K961685Class IIP.f.c. Cruciate Retaining Knee System (Size 1.5)Johnson & Johnson Professionals, Inc. / cleared 1996-07-10

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)