DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO sur
FDA device recall Z-0508-2024 · posted 2023-12-07 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Due to incorrect product/device within packaging.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 37 devices
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-11-10
- Date posted
- 2023-12-07
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPOWR Porous Knee System (K171991) | Encore Medical L.P. | 2017-10-04 |