FDA Medical devices recall ·
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE recall
- Recall number
- Z-0766-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Encore Medical, LP
9800 Metric Blvd, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 33
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Why was it recalled?
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
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
REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086
Distribution
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
States: Arizona California Florida Iowa Illinois Indiana Maryland Minnesota New York South Carolina Texas Virginia Washington Wisconsin
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-0766-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.