FDA Medical Device Recalls (openFDA)
Encore Medical, LP: EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
- Recall number
- Z-0761-2025
- Recalling firm
- Encore Medical, LP
- Product
- EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
- Status
- Open, Classified
- Initiated
- 2024-12-10
- Posted
- 2024-12-23
- Terminated
- not on file
- Reason
- Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
- Root cause
- Labeling Change Control
- Action
- On 12/10/2024, recall notices were emailed to customers asking them 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
- Quantity
- 9
- Distribution
- US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
- Lot, serial or model codes
- UDI-DI: 00888912167338. Lot: 076T1273A
- 510(k) numbers
- ["K143242"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28