FDA Medical Device Recalls (openFDA)
Encore Medical, LP: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Recall number
- Z-1233-2026
- Recalling firm
- Encore Medical, LP
- Product
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Status
- Open, Classified
- Initiated
- 2026-01-05
- Posted
- 2026-02-02
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling Change Control
- Action
- 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
- Quantity
- 19
- Distribution
- US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
- Lot, serial or model codes
- UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
- 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