EMPOWR Knee Patella Drill (Unknown) - Incorrect Diameter (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Lot Codes / Batch Numbers
REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01, 802-05-108/00190446365907/388620L03
Products Sold
REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03
A medical device manufacturer is recalling EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 due to Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diamet. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, HI, IN, KS, MD, TX, WA
Page updated: Jan 10, 2026