Z-0399-2008

Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V...

Name: Z-0399-2008 Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V...
Creator: Depuy Orthopaedics, Inc.
Published: 2007-09-27
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2007-09-27 / Terminated / root cause: packaging

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527 on 2007-09-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0399-2008
Status: Terminated
Initiated: 2007-09-27
Posted: 2007-12-06
Terminated: 2008-04-30
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: 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 tag: packaging
FDA root cause: Packaging process control
Action: Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
Quantity in commerce: 12
Distribution: Nationwide.
Product codes and lots: Lot 79272A.

Product code NJL

K952830Class IIDarwin Knee System (Tc3)Johnson & Johnson Professionals, Inc. / cleared 1996-01-18

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)