EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
FDA device recall Z-0102-2024 · posted 2023-10-12 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
- Action taken
- On 8/22/23, recall notices were emailed to agents who were asked to do the following: 1) Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. 2) The notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. If you have any questions, email productsafety@enovis.com
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 36
- Distribution
- US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
- Date initiated
- 2023-08-22
- Date posted
- 2023-10-12
- 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 |