Recall Z-0480-2021 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Encore Medical, LP
EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
| Date | Jun 19, 2020 |
| Status | Open, Classified |
| Reason | There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur. |
| Root cause | Other |
| Action | The method of notification was via e-mail to surgical sales agents, and the notices were issued on 06/18/2020. Additionally, a notification to return the affected drills for replacement were sent via e-mail to affected surgical agents on 07/20/20. The following recommendations should be communicated to the implanting surgeons: Sales Agents Action: To avoid the potential binding, the following is recommended: " Use a plunge mill approach, i.e. plunge the drill in and out of the drill guide bushing a few times slowly until the hole is fully prepared. " Use of saline or fat to keep the drill l |
| Quantity | 28 units |
| Distribution | US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191325 | EMPOWR Partial Knee Encore Medical L.P., Jul 16, 2019 |