Brand Name: EMPOWR 3D KNEE TIBIAL INSERT — Class II medical device recall Z-2126-2025

Ongoing recall by Encore Medical, LP, reported 2025-07-23, distributed in AZ, IA, ID, IL, IN, LA, MI, MO…. Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this produc

Recall number	`Z-2126-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Encore Medical, LP, Austin, TX, United States
Recall initiated	2025-06-02
Classified	2025-07-17
Reported by FDA	2025-07-23
Distributed	AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, WA
Quantity	20
UPC / GTIN / UDI-DI	`00888912166980`
Lot numbers	`115T1077`
Model numbers	`341-12-711`

Product

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 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

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2126-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.