Knee Patella Drills Recalled for Incorrect Diameter Markings
Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk of implant loosening, improper fitting, or bone fracture if incorrect drill is used during surgery. No illnesses or injuries have been reported.
Plain-English summary
Encore Medical, LP is recalling EMPOWR Porous Knee Patella Over Drills (REF 802-05-104) and EMPOWR Knee Patella Drills (REF 802-05-108) due to incorrect diameter markings. The patella drills are marked as 5.6mm when they should be 5.4mm, and the porous patella overdrills are marked as 5.4mm when they should be 5.6mm.
If a surgeon selects the incorrect drill during knee surgery, there is risk of the implant loosening, improper fitting, or fractured bone.
The affected devices were distributed to healthcare facilities in Texas, Indiana, Maryland, California, Kansas, Alabama, Hawaii, and Washington. 29 units total were distributed. Healthcare providers should verify the correct drill diameter before use and contact the manufacturer or the FDA with questions.
The recalled product
- Product
- EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
- Manufacturer
- Encore Medical, LP
- Hazard
- implant-loosening
- bone-fracture
- mis-marking
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01
- 802-05-108/00190446365907/388620L03
Distribution
Distributed in 8 states:
- AL
- CA
- HI
- IN
- KS
- MD
- TX
- WA
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