Reported Apr 19, 2023 · Ongoing
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- EMPOWR Porous Knee Patella Over Drill
- REF802-05-104; EMPOWR Knee Patella Drill
- REF802-05-108
- Lot codes and dates
2 of 2 products · 2 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Lot 802-05-10400190446238843388620L01
802-05-10800190446365907388620L03
- Amount recalled
- 29
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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