FDA Medical Device Recalls (openFDA)
Encore Medical, LP: EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
- Recall number
- Z-0102-2024
- Recalling firm
- Encore Medical, LP
- Product
- EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
- Status
- Open, Classified
- Initiated
- 2023-08-22
- Posted
- 2023-10-12
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Labeling Change Control
- Action
- 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
- Quantity
- 36
- Distribution
- US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
- Lot, serial or model codes
- UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
- 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