Z-2125-2025 Class II Ongoing
FDA device recall Z-2125-2025 was initiated by Encore Medical, LP on Jun 2, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 20.
Recall details
- Product Type
- Devices
- Report Date
- Jul 23, 2025
- Initiation Date
- Jun 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product description
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
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.
Distribution pattern
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
Code information
Lot Code: Item: 341-10-711 GTIN: 00888912166881 Lot\s: 071T1084
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2125-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026