Recall Z-2949-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
| Date | Jul 18, 2018 |
| Status | Terminated |
| Reason | This unit may be missing the screw/collet Assembly |
| 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 surg |
| Quantity | 1 |
| Distribution | The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952830 | DARWIN KNEE SYSTEM (TC3) Johnson & Johnson Professionals, Inc., Jan 18, 1996 |