TEMA Axle Small recall
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Why was TEMA Axle Small recalled?
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
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 Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
- Product
- TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 5 systems
- Distribution
- U.S. Distribution to: TX
- Recall date
- March 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)