Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 32mm) due to reduced grip strength from incorrect titanium. Affected units have specific batch numbers and GTIN. Contact for return or repair.
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 certain Infinity Multi-Axial Screws because they use incorrect titanium that weakens the screw's grip. This could lead to the spinal implant failing, potentially causing pain or instability in the neck or upper back area.
The screws use a type of titanium that reduces the screw's ability to hold securely in place. This could cause the implant to loosen over time, leading to instability in the spine and potential pain or injury.
People who have received the Infinity Multi-Axial Screw (4.0mm x 32mm) for spinal stabilization are affected. Patients with recent spinal surgery or those using this implant for neck/back support are at higher risk.
Check for the product name 'Infinity Occipitocervical Upper Thoracic System', size 4.0mm x 32mm, and batch number H5802984. The GTIN is 00643169541856. This product was sold for spinal stabilization procedures.
Identify the batch number and GTIN to confirm if your device is affected.
Reach out to Medtronic Sofamor Danek for instructions on returning or repairing the device.
The screws use incorrect titanium that reduces grip strength, which could cause the implant to loosen and lead to instability.
Check the batch number and GTIN to confirm if your device is affected, then contact Medtronic Sofamor Danek for return or repair instructions.
While the screws may loosen over time, the recall is for safety; the manufacturer recommends checking and contacting them to prevent potential instability.
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-1410-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1410-2023 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.
