Recall Z-0329-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
| Date | Dec 12, 2017 |
| Status | Terminated |
| Reason | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. |
| Root cause | Device Design |
| Action | The field safety notice was disseminated by email on 12/12/2017. The notice stated the following: "DJO Sales Agents Action: Please review the bulletin that is provided with this notice. This bulletin contains new instructions on the use of the Locking Punch Guide and Punch. Please ensure your surgeons are familiar with this information. DJO Surgical then requires that you complete the attached acknowledgment and email it to teffany.hutto@djoglobal.com. Please have this form returned by December 15, 2017 Once redesigned guides are available, they will be exchanged through a separate fi |
| Quantity | 2 units |
| Distribution | One medical device distributor in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100900 | MOTIVATION KNEE SYSTEM Encore Medical L.P., Jun 18, 2010 |