Medtronic Sofamor Danek recalls 5 batches of Infinity Multi-Axial Screws (4.0mm x 26mm) due to incorrect titanium reducing screw grip strength. Affected patients should contact for replacement.
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Medtronic Sofamor Danek is recalling 5 batches of Infinity Multi-Axial Screws (4.0mm x 26mm) because they used incorrect titanium, which weakens the screw's grip strength. This could lead to improper spinal stabilization and potential complications after surgery.
The screws use incorrect titanium that reduces grip strength, meaning they may not hold properly during spinal fusion. This could cause the screws to loosen or fail, potentially leading to instability in the spine.
Patients who received the recalled screws during spinal fusion surgery are affected. Those with the specific batch numbers (H5806345) are most at risk.
Check for the product name 'Infinity Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026'. The batch number is H5806345.
Reach out to Medtronic Sofamor Danek for a replacement or refund if you have the recalled screws.
The screws used incorrect titanium which reduces grip strength, potentially causing improper spinal stabilization.
Batch number H5806345.
No, but you should contact Medtronic Sofamor Danek for a replacement if you have the recalled screws.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-1412-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1412-2023 from Medtronic Sofamor Danek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
