Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 34mm) due to reduced grip strength from incorrect titanium. Affected units have batch numbers H5806345. 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 for spinal surgery because they use incorrect titanium that weakens the screw's grip. This could lead to the implant failing during spinal fusion procedures, potentially causing pain or instability.
The screws use a different type of titanium than intended, which reduces their ability to hold securely in the spine. This could cause the screw to loosen or fail during spinal fusion, leading to instability or pain.
Patients who received the Infinity Multi-Axial Screws (4.0mm x 34mm) with batch number H5806345 for spinal fusion are affected. Surgeons and medical staff using these screws in procedures are at risk.
Check if your Infinity Multi-Axial Screw is labeled as 4.0mm x 34mm with batch number H5806345. These screws were used for spinal fusion procedures.
Identify if your screw has the batch number H5806345 and size 4.0mm x 34mm.
Reach out to Medtronic Sofamor Danek for instructions on returning or repairing the screw.
The screws use incorrect titanium that reduces grip strength, which could cause failure during spinal fusion procedures.
Check if your screw has batch number H5806345 and size 4.0mm x 34mm. Contact Medtronic Sofamor Danek for return or repair instructions.
Yes, the reduced grip strength could lead to screw failure, causing pain or instability during spinal fusion.
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-1413-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1413-2023 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.
