EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
FDA device recall Z-0766-2025 · posted 2024-12-26 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
- Action taken
- On 12/18/2024, recall notices were emailed to consignees who were asked to do the following: 1. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com If you have questions contact the firm at productsafety@enovis.com
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 33
- Distribution
- US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
- Date initiated
- 2024-12-18
- Date posted
- 2024-12-26
- 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 |
|---|---|---|
| Rebel 3DKNEE System (K143242) | Encore Medical L.P. | 2015-05-15 |