FDA Medical Device Recalls (openFDA)
Encore Medical, LP: Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
- Recall number
- Z-2125-2025
- Recalling firm
- Encore Medical, LP
- Product
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
- Status
- Open, Classified
- Initiated
- 2025-06-02
- Posted
- 2025-07-17
- Terminated
- not on file
- Reason
- Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Root cause
- Packaging change control
- Action
- On 06/02/2025, the firm emailed an "Urgent: Medical Device Recall" letter to customers. The letter described the product, problem and actions to be taken. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This notice needs to be passed on to all those within their organization or to any organization where the product has been transferred. 3.Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through their regional email address, to place a replacement request. They will be provided with an RMA number and shipping label to return the affected product. 4.Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. Any questions, contact Recall Coordinator at productsafety@enovis.com or call/text 682-299-9133.
- Quantity
- 20
- Distribution
- U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA
- Lot, serial or model codes
- Lot Code: Item: 341-10-711 GTIN: 00888912166881 Lot\s: 071T1084
- 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