FDA-Device2023-04-19Class II
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Encore Medical, LP
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.
Sold states
US: TX, IN, MD, CA, KS, AL, HI, WA
Affected count
29
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1384-2023Don't want to check this manually?
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