Device product

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

Z-1384-2023

February 28, 2023

Class II

Product summary

Firm: Encore Medical, LP
Event: Event 91906
Status: Ongoing
Classification: Class II
Quantity: 29
Official record key: device-enforcement:Z-1384-2023

Official wording

Reason: 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.

Code information: REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03

Distribution pattern: US: TX, IN, MD, CA, KS, AL, HI, WA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.