EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
- Recall Initiated
- February 28, 2023
- Posted
- April 12, 2023
- Recall Number
- Z-1384-2023
- Quantity
- 29
- Firm Location
- Austin, TX
Reason for Recall
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.
Distribution
US: TX, IN, MD, CA, KS, AL, HI, WA
Lot / Code Info
REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03
Root Cause
Process change control
Action Taken
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.