INFINITY Occipitocervical Upper Thoracic System recall
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal…
Why was INFINITY Occipitocervical Upper Thoracic System recalled?
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
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?
GTIN 00643169541856, Lot/Batch numbers: H5802984
- Product
- INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal…
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 10 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- April 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)