FDA recall Z-2949-2018

DePuy Orthopaedics, Inc. · Class II · device

Product

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

Reason for recall

This unit may be missing the screw/collet Assembly

Distribution

The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.

Key facts

Status
Terminated
Initiation date
2018-07-18
Report date
2018-09-05
Termination date
2019-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2949-2018