Osteomed recalls sterile surgical screws with a potential risk of the screw passing through the plate hole during osteotomies. Affected units include specific lot numbers and model designations.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Osteomed is recalling sterile surgical screws that may have an undersized screwhead, which could pass through the plate hole during osteotomies. This poses a risk of improper fixation and potential complications for patients.
The screws have an undersized screwhead that can pass through the plate hole during osteotomy procedures. This may lead to improper fixation of bone fragments and potential complications such as misalignment or infection.
Surgical patients and healthcare providers who use these specific screws for osteotomies. Patients with the recalled lot numbers are most at risk.
Check for the model: 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile. Lot numbers 1177027, 1177718, or 1177812 are affected. These were sold with UDI-DI: (01)00845694034258.
Verify the lot number and model designation to confirm if your screw is affected.
The screws have an undersized screwhead that can pass through the plate hole during osteotomy procedures, potentially causing improper bone fixation.
Check the lot number and model designation to confirm if your screws are affected. If they are, contact Osteomed for further instructions.
The recall is for potential improper fixation during osteotomies, but no specific injuries have been reported. Patients should follow the manufacturer's guidance.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2107-2023 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2107-2023 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.
