Z-1077-2014Class II

PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee...

Name: Z-1077-2014 PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee...
Creator: DePuy Orthopaedics, Inc.
Published: 2013-12-09
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2013-12-09 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility on 2013-12-09. FDA classified it as Class II and gives the reason as "Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength...". 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-1077-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Posted: 2014-02-24
Terminated: 2014-06-10
Recalling firm: Depuy Orthopaedics Inc.
Product: PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recall is extended to the DePuy Distributor, Hospital, and Surgeon levels. The two affected distributors were contacted by telephone. Written communication to the two hospitals and one surgeon who received the devices will be delivered by DePuy Orthopaedics, Inc. via email or regular mail. The one affected surgeon will also be contacted by telephone by the Medical Safety Officer and a metallurgist, who will discuss the surgeon communication with the surgeon. The sales representatives aid customers in the affected device returns, as needed. The devices will be returned through the normal DePuy Returns process, to attention of Returns and marking H13-30C on the outside of the box. All (21) remaining devices have been verified as being returned and in quarantine. Effectiveness will be determined by product reconciliation, receipt of all hospital reconciliation forms, and receipt of international declaration from the International Affiliate. DePuy will follow-up with the affected hospitals until all hospital reconciliation forms are returned, and DePuy will follow-up with the International Affiliate until all international actions are complete and the international declaration is completed and return.
Quantity in commerce: 2
Distribution: Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
Product codes and lots: Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1077-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1077-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

Product code JWH

K943462Class IIDarwin Knee SystemJohnson & Johnson Professionals, Inc. / cleared 1994-12-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)