Acumed LLC recalls Dual-Trak Clavicle Screws (part numbers 40-0136 to 40-0147) due to distribution without pre-market clearance. Affected units include specific sizes and batch numbers.
Distribution without Pre-Market Clearance
Acumed LLC is recalling a range of Dual-Trak Clavicle Screws (part numbers 40-0136 to 40-0147) because they were distributed without proper pre-market clearance. This means the screws may not have been approved for safety before being sold.
The recall is due to distribution without pre-market clearance, meaning the screws were sold without being approved by the appropriate regulatory bodies. This could potentially lead to safety issues if the screws do not meet required standards for medical use.
Medical professionals and patients who own or use these specific Dual-Trak Clavicle Screws for surgical procedures are likely affected. The risk is primarily for those who have the recalled part numbers.
Check for part numbers 40-0136 to 40-0147 on the screws. The specific batch numbers and UDI codes listed in the recall notice also help identify affected units.
Look for part numbers 40-0136 to 40-0147 on the screws and verify the batch numbers or UDI codes listed in the recall notice.
The product was distributed without pre-market clearance, meaning it was sold without being approved by the appropriate regulatory bodies.
Check for part numbers 40-0136 to 40-0147 on the screws and verify the batch numbers or UDI codes listed in the recall notice.
The recall notice does not specify a remedy, so you should check with Acumed LLC for further instructions.
We’ve drafted a message you can send Acumed to request your refund or repair — edit it as you like.
Subject: Recall Z-0770-2023 — Acumed Acumed Hello, I own a Acumed that is covered by recall Z-0770-2023 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.
