Z-2285-2025 Class II Ongoing
FDA device recall Z-2285-2025 was initiated by Encore Medical, LP on Jul 9, 2025 and is designated Class II. Reason for recall: Knee implants contain incorrect labeling (size and/or side incorrect) The recall status is ongoing. Affected quantity: 18 implants.
Recall details
- Product Type
- Devices
- Report Date
- Aug 20, 2025
- Initiation Date
- Jul 9, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 implants
Product description
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 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.
Reason for recall
Knee implants contain incorrect labeling (size and/or side incorrect)
Distribution pattern
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
Code information
Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2285-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026