Z-2949-2018Class II

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

Name: Z-2949-2018 P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Creator: DePuy Orthopaedics, Inc.
Published: 2018-07-18
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2018-07-18 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 on 2018-07-18. FDA classified it as Class II and gives the reason as "This unit may be missing the screw/collet Assembly". 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-2949-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Posted: 2018-08-29
Terminated: 2019-04-17
Recalling firm: Depuy Orthopaedics Inc.
Product: P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: This unit may be missing the screw/collet Assembly
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The notification letter distributed in July 2018 instructed the customer to perform the following actions: " Please cease using the affected device immediately. " Medical facility to return affected implant immediately to their Sales Consultant. " Review this notice and complete the Acknowledgement section (Attachment A) to signify that your facility has been informed of this recall. Return the completed Acknowledgement to your Sales Consultant within five (5) working days of this notice. " Retain a copy of the completed Acknowledgement Form in your files along with this notice. " Notify surgeons at your facility by providing them with a copy of this notice to ensure surgeons are aware of this recall. " Share this notice with others in your facility who need to be informed.
Quantity in commerce: 1
Distribution: The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
Product codes and lots: Lot: C2KJ24, GTIN: 10603295234135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2949-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2949-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29

Product code JWH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)