EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
FDA device recall Z-1384-2023 · posted 2023-04-12 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- 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.
- Action taken
- 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, customerservice@enovis.com, was provided to report failures or to request replacements. Customers with questions can phone (914) 450-3931, or email livia.kuruvila@enovis.com.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 29
- Distribution
- US: TX, IN, MD, CA, KS, AL, HI, WA
- Date initiated
- 2023-02-28
- Date posted
- 2023-04-12
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Porous Patella (K212941) | Encore Medical, L.P. Dba Djo Surgical | 2022-01-20 |