Medtronic Sofamor Danek recalls Vertex Select Multi Axial Screws (4.0 x 38mm) with shorter length than labeled. Affected units may not fit properly in spinal surgery.
Nonconforming product; length of the product measured shorter than the labeled length.
Medtronic Sofamor Danek is recalling certain Vertex Select Multi Axial Screws (4.0 x 38mm) because they are shorter than labeled. This could cause improper fitting during spinal surgery, potentially leading to complications.
The screws are shorter than labeled, which could lead to improper placement in spinal surgery. This might cause instability or misalignment of the spine during healing.
Surgical teams using these screws for spinal procedures are most at risk. Patients receiving these screws during surgery may face improper fixation.
Check for the product name 'VERTEX SELECT MULTI AXIAL SCREW', size '4.0 X 38MM', and lot number H5517628. The product number is 6958838.
Verify the product name, size, and lot number to confirm if your item is affected.
The screws are shorter than labeled, which could cause improper fitting during spinal surgery.
The recall does not specify a remedy, so check with Medtronic Sofamor Danek for guidance.
The recall states nonconforming product but does not mention serious injury risk, so the risk is low.
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-1941-2020 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1941-2020 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.
