Recall Z-0258-2024 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Encore Medical, LP
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
| Date | Nov 7, 2023 (initiated Sep 29, 2023) |
| Status | Open, Classified |
| Reason | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. |
| Root cause | Process change control |
| Action | On 9/29/23, recall notices were emailed to customers who were asked to do the following: 1) Knee punch handles should be visually inspected prior to use for any damage. Upon completion of surgery, visually inspect and verify there is no breakage. The attached quality bulletin provides guidance on an acceptable and unacceptable device. 2) Contact your customer service rep at customerservice@enovis.com to report failures or to request replacements. 3) Complete and return the response form that asks customers to check all related devices in inventory and report the number of related devices |
| Quantity | 406 |
| Distribution | US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171991 | EMPOWR Porous Knee System Encore Medical L.P., Oct 4, 2017 |