FDA Medical devices recall ·
EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS… recall
- Recall number
- Z-2285-2025
- Date
- (initiated July 9, 2025)
- Company / brand
- Encore Medical, LP
9800 Metric Blvd, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18 implants
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Knee implants contain incorrect labeling (size and/or side incorrect)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
States: Alabama Arizona California Colorado Florida Iowa Illinois Indiana Kansas Louisiana New York Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2285-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.