FDA Medical devices recall ·
EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model recall
- Recall number
- Z-1459-2026
- Date
- (initiated January 15, 2026)
- Company / brand
- Encore Medical, LP
9800 Metric Blvd, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14 implants
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Why was it recalled?
Knee and Humeral socket implants contain incorrect labeling.
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: Lot: 151T1055A GTIN: 00888912167147
Distribution
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
States: California Colorado Florida Illinois Indiana Louisiana Massachusetts Michigan Missouri Montana New Jersey Oklahoma Pennsylvania Rhode Island Tennessee Virginia Wyoming
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-1459-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.