EMPOWR Porous Knee Patella Over Drill recall
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Why was EMPOWR Porous Knee Patella Over Drill 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03
- Product
- EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
- Recalling firm
- Encore Medical, LP
- Quantity
- 29
- Distribution
- US: TX, IN, MD, CA, KS, AL, HI, WA
- Recall date
- April 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)