P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
This recall has been terminated (originally issued July 18, 2018).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- July 18, 2018
- Terminated
- April 17, 2019
- Recall Number
- Z-2949-2018
- Quantity
- 1
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot: C2KJ24, GTIN: 10603295234135
Root Cause
Employee error
Action Taken
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.