PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 5, 2018 Initiated: July 18, 2018 #Z-2949-2018

Product Description

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

Reason for Recall

This unit may be missing the screw/collet Assembly

Details

Recalling Firm
DePuy Orthopaedics, Inc.
Units Affected
1
Distribution
The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830. Recalled by DePuy Orthopaedics, Inc.. Units affected: 1.
Why was this product recalled?
This unit may be missing the screw/collet Assembly
Which agency issued this recall?
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2949-2018.