FDA Medical devices recall ·
TEMA Elbow - Axle Small recall
- Recall number
- Z-0744-2025
- Date
- (initiated October 2, 2024)
- Company / brand
- Limacorporate S.p.A
Via Nazionale 52, San Daniele Del Friuli, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- ~87 devices (U.S.)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Why was it recalled?
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during 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
Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193
Distribution
U.S: FL and TX O.U.S.: N/A
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-0744-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.