Recall Z-1384-2023 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Encore Medical, LP
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
| Date | Apr 12, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone. |
| Root cause | Process change control |
| Action | On 2/28/23, field safety notices were emailed to surgical sales agents who were asked to document the quantity of affected devices complete and return the acknowledgement form. Customer service contact, customerservice@enovis.com, was provided to report failures or to request replacements. Customers with questions can phone (914) 450-3931, or email livia.kuruvila@enovis.com. |
| Quantity | 29 |
| Distribution | US: TX, IN, MD, CA, KS, AL, HI, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212941 | Porous Patella Encore Medical, L.P. Dba Djo Surgical, Jan 20, 2022 |