Z-1384-2023 Class II Ongoing
FDA device recall Z-1384-2023 was initiated by Encore Medical, LP on Feb 28, 2023 and is designated Class II. Reason for recall: 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 recall status is ongoing. Affected quantity: 29.
Recall details
- Product Type
- Devices
- Report Date
- Apr 19, 2023
- Initiation Date
- Feb 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
Product description
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Reason for recall
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.
Distribution pattern
US: TX, IN, MD, CA, KS, AL, HI, WA
Code information
REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1384-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026