Acumed recalls 4.0mm x 12mm cannulated screws (part 3005-40012) produced from Aug 2018 to Feb 2022 due to potential bone damage risks. Affected units have specific batch dates and UDI codes.
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Acumed is recalling 4.0mm x 12mm cannulated screws that may not hold bone fragments securely, risking malunion, fractures, or soft tissue damage. This affects surgeons and medical facilities using these screws in orthopedic procedures.
The screws may not provide enough strength to hold bone fragments together during healing. This could lead to improper bone alignment, fractures, joint damage, or soft tissue injuries if the screws fail under stress.
Surgeons and medical facilities using the recalled screws for orthopedic procedures are most at risk. Patients receiving these screws during surgery may experience complications.
Check for part number 3005-40012 with batch dates from August 22, 2018 to February 7, 2022. The unique device identifier (UDI) is 10806378022876.
Verify the part number and batch dates to confirm if your screw is affected.
The part number is 3005-40012.
Batch dates range from August 22, 2018 to February 7, 2022.
The recall record does not specify a remedy.
We’ve drafted a message you can send Acumed to request your refund or repair — edit it as you like.
Subject: Recall Z-0959-2022 — Acumed Acumed Hello, I own a Acumed that is covered by recall Z-0959-2022 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.
