Cortera Spinal Fixation System recall: Labeling Error
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Why was Cortera Spinal Fixation System recalled?
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
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?
UDI-DI: 00810076564005, Lot: AP23000143
- Product
- Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
- Recalling firm
- XTANT Medical Holdings, Inc
- Quantity
- 6
- Distribution
- US distribution in MI.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)