FDA Medical devices recall ·
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE recall
- Recall number
- Z-1233-2026
- Date
- (initiated January 5, 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
- 19
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Why was it recalled?
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
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
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
States: Alabama California Iowa Massachusetts Michigan Missouri Mississippi New Jersey New York Oklahoma Pennsylvania Puerto Rico Rhode Island 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-1233-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.