EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA device recall Z-1233-2026 · posted 2026-02-02 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
- Action taken
- On 1/5/2026, recall notices were emailed to customers 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) Contact the firm to arrange for affected device return. 3. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com Customers with questions can email the firm at productsafety@enovis.com
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 19
- Distribution
- US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
- Date initiated
- 2026-01-05
- Date posted
- 2026-02-02
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rebel 3DKNEE System (K143242) | Encore Medical L.P. | 2015-05-15 |