TEMA Elbow - Axle Small recall
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 TEMA Elbow - Axle Small recalled?
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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.
- Recalling firm
- Limacorporate S.p.A
- Quantity
- ~87 devices (U.S.)
- Distribution
- U.S: FL and TX O.U.S.: N/A
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)