Medtronic Sofamor Danek recalls 5 batches of Infinity Occipitocervical Upper Thoracic System screws due to incorrect titanium reducing grip strength. Affected units have specific lot numbers and sizes.
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 Occipitocervical Upper Thoracic System screws because they used incorrect titanium, which reduces the screw's grip strength. This could lead to the screws loosening over time and potentially causing spinal instability.
The screws use incorrect titanium that reduces grip strength, making them less secure in the spine. This could cause the screws to loosen over time, potentially leading to spinal instability or failure of the surgical fix.
Patients who received the Infinity Occipitocervical Upper Thoracic System with the specific screw size (4.0mm x 22mm) and lot numbers H5806333 are affected. Spinal surgery patients are most at risk.
Check if your Infinity Occipitocervical Upper Thoracic System has a screw size of 4.0mm x 22mm and lot number H5806333. The product was sold with GTIN 00643169552654.
Verify if your Infinity Occipitocervical Upper Thoracic System has a screw size of 4.0mm x 22mm and lot number H5806333.
The screws used incorrect titanium which reduces grip strength, potentially causing loosening over time.
Check if your product matches the specific screw size and lot number; if so, contact Medtronic Sofamor Danek for further instructions.
The recall indicates reduced grip strength, but no specific injury reports were mentioned in the official notice.
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-1411-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1411-2023 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.
