EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104 recallZ-1384-2023 · Encore Medical, LP · initiated Feb 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process change control
What the company is doing
On 2/28/23, field safety notices were emailed to surgical sales agents who were asked to document the quantity of affected devices complete and return the acknowledgement form. Customer service contact, [email protected], was provided to report failures or to request replacements. Customers with questions can phone (914) 450-3931, or email [email protected].
Recall details
- Recall number
- Z-1384-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 28, 2023
- Posted by the FDA
- Apr 12, 2023
- Recalling firm
- Encore Medical, LP
- Quantity
- 29
- Product code
- MBH
- FDA submissions
- K212941
- Distribution
- US: TX, IN, MD, CA, KS, AL, HI, WA
Product description
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Code information (models, lots, serial numbers)
REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 802-05-104Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- DJO SURGICAL 802-05-108Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
Other devices under the same FDA submission
5 devices cleared under K212941 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 110-03-735Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- DJO SURGICAL 802-05-107Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- DJO SURGICAL 110-03-729Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- DJO SURGICAL 110-03-732Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- DJO SURGICAL 110-03-738Encore Medical, L.P. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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