Home / Recalls / Medical Devices
Encore Medical, LP recalls EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Recalled April 19, 2023 · FDA recall Z-1384-2023 · Encore Medical
Hazard
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. · FDA Class II
Units
29
Sold at
US: TX, IN, MD, CA, KS, AL, HI, WA
Description
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.
Product
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Manufacturer(s)
Encore Medical, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →