XTANT recalls spinal fixation screws labeled as 8.5mm diameter, 50mm length that are actually 5.5mm diameter, 45mm length. Incorrect labeling risks poor screw engagement in spinal surgery.
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
XTANT is recalling spinal fixation screws that are labeled incorrectly. The screws are actually smaller (5.5mm diameter, 45mm length) than labeled (8.5mm diameter, 50mm length), which could cause them to not engage properly in spinal surgery. This poses a risk of improper spinal fixation during procedures.
The screws are labeled as 8.5mm diameter, 50mm length but are actually 5.5mm diameter, 45mm length. This size difference means they may not engage properly in spinal bone fixation, potentially leading to unstable spinal repairs.
Patients undergoing spinal surgery who received these screws are likely affected. Surgeons and medical facilities using the recalled screws are at risk of improper spinal fixation.
Check for spinal fixation screws labeled as 8.5 mm diameter, 50 mm length with UDI-DI: 00810076564005 and Lot: AP23000143. The screws are part of the Cortera Spinal Fixation System, REF: 150100-85050.
Verify if your spinal fixation screws are labeled as 8.5 mm diameter, 50 mm length with UDI-DI: 00810076564005 and Lot: AP23000143.
The screws are labeled as 8.5 mm diameter, 50 mm length but are actually 5.5 mm diameter, 45 mm length, which may cause them to not engage properly in spinal fixation.
The recall record does not specify a remedy, so check with your surgeon or medical facility for guidance.
Look for spinal fixation screws labeled as 8.5 mm diameter, 50 mm length with UDI-DI: 00810076564005 and Lot: AP23000143.
We’ve drafted a message you can send XTANT to request your refund or repair — edit it as you like.
Subject: Recall Z-0846-2024 — XTANT XTANT Hello, I own a XTANT that is covered by recall Z-0846-2024 from XTANT. 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.
