Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 24mm) due to weak grip from incorrect titanium. Affected units have batch H5802983. Contact for remedy.
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 24mm) because they use incorrect titanium that reduces screw grip strength. This could lead to improper spinal stabilization during fusion surgery.
The screws use a weaker type of titanium that doesn't hold as tightly. This could cause the screw to loosen during spinal fusion surgery, potentially leading to instability in the spine.
Patients who received this specific spinal screw during surgery are affected. Surgeons and medical staff using these screws for spinal fusion procedures are at risk.
Check for batch number H5802983 on the screw packaging. The product is part of the Infinity Occipitocervical Upper Thoracic System for spinal fusion.
Look for batch number H5802983 on the screw packaging or surgical records.
The screws use incorrect titanium that reduces grip strength, which could cause loosening during spinal fusion surgery.
Check for batch number H5802983 on the screw packaging or surgical records.
The recall record does not specify a remedy, so contact Medtronic Sofamor Danek directly for guidance.
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-1409-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1409-2023 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.
