Z-1318-05

Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361

Name: Z-1318-05 Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361
Creator: Depuy Orthopaedics, Inc.
Published: 2005-05-26
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2005-05-26 / Terminated / root cause: packaging

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361 on 2005-05-26. 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-1318-05
Status: Terminated
Initiated: 2005-05-26
Posted: 2005-08-12
Terminated: 2005-12-02
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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: Other
Quantity in commerce: 10
Distribution: Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
Product codes and lots: Lot Y88D94.

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)