Acumed recalls Acutrak Compression Screws (10mm-26mm) due to distribution without pre-market clearance. This may pose regulatory risks but does not indicate immediate safety hazards. Affected units include specific part numbers and batch codes listed in the recall.
Distribution without Pre-Market Clearance
Acumed is recalling Acutrak Compression Screws (10mm to 26mm) because they were distributed without proper pre-market clearance. This is a regulatory issue that does not involve immediate safety risks like injuries or damage. The recall is for compliance purposes, not because the product is unsafe.
The product was distributed without pre-market clearance, meaning it wasn't approved by the relevant regulatory bodies before being sold. This is a compliance issue that does not cause immediate harm but requires correction to meet regulatory standards.
Medical professionals and surgical teams who use these screws for procedures are likely affected. The risk is minimal as this is a regulatory oversight, not a safety hazard.
Check if your screws have part numbers like AI-0010-S (10mm) through AI-0026-S (26mm) or batch codes starting with 204010, 204011, etc. The recall covers specific sizes and batch numbers listed in the official notice.
Look for part numbers like AI-0010-S (10mm) through AI-0026-S (26mm) or batch codes starting with 204010, 204011, etc.
Acumed is recalling these screws because they were distributed without pre-market clearance, which is a regulatory compliance issue. This does not indicate an immediate safety hazard.
No, this recall is for regulatory compliance, not safety. You can continue using the screws as long as they are within the specified part numbers and batch codes.
Check the part number on the screw (e.g., AI-0010-S for 10mm) and the batch code (e.g., 204010, 204011) listed in the official recall notice.
We’ve drafted a message you can send Acumed to request your refund or repair — edit it as you like.
Subject: Recall Z-0769-2023 — Acumed Acumed Hello, I own a Acumed that is covered by recall Z-0769-2023 from Acumed. 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.
