Osteomed recalls sterile 4mm AutoDrive screws for osteotomies due to potential screwhead undersizing that could pass through plate holes. Affected lots: 1177274, 1177331, 1177823. Contact for return instructions.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Osteomed is recalling sterile 4mm AutoDrive screws for osteotomies because the screwheads may be too small and could pass through the plate hole during surgery. This poses a risk of improper fixation and potential complications if the screw moves through the bone plate.
The screwheads are undersized and could pass through the plate hole during surgery. This might cause the screw to move through the bone plate, leading to improper fixation and potential complications like bone displacement or infection.
Surgical patients and healthcare providers who use these screws for osteotomies. Patients undergoing bone surgery with this specific screw model are most at risk.
Check for the product name: Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile. Affected lots are 1177274, 1177331, and 1177823. These screws were sold with the UDI-DI code (01)00845694066006.
Look for the lot numbers 1177274, 1177331, or 1177823 on the packaging or label.
Reach out to Osteomed directly for return or replacement instructions once you confirm the affected lot number.
The screwheads are undersized and could pass through the plate hole during surgery, potentially causing improper fixation and complications like bone displacement.
Affected lot numbers are 1177274, 1177331, and 1177823.
Check for the product name: Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile. Affected lots are 1177274, 1177331, and 1177823.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2108-2023 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2108-2023 from Osteomed. 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.
