Acumed recalls 4.0mm x 10mm cannulated screws (batch 22 AUG 2018 - 07 FEB 2022) due to potential bone fracture risks. Affected users should contact Acumed for details.
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 10mm cannulated screws produced between August 2018 and February 2022. These screws may not hold bone fragments securely, risking fractures or joint damage during surgery.
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 injury.
Orthopedic surgeons and medical professionals using these screws for bone fixation. Patients who have received this specific screw type during surgery are at risk.
Check for part number 3005-40010 on the screw packaging. The batch dates range from August 22, 2018, to February 7, 2022. The unique device identifier (UDI) is 10806378022869.
Verify the part number (3005-40010) and batch dates (August 22, 2018 - February 7, 2022) on the screw packaging.
Reach out to Acumed LLC for guidance on next steps and potential remedies.
The screws may not have sufficient strength to hold bone fragments securely, which could lead to fractures, joint damage, or soft tissue injury.
Contact Acumed LLC directly for specific instructions on how to handle the recalled screws.
Yes, patients who received this screw during surgery may face risks of improper healing, fractures, or joint damage.
We’ve drafted a message you can send Acumed to request your refund or repair — edit it as you like.
Subject: Recall Z-0958-2022 — Acumed Acumed Hello, I own a Acumed that is covered by recall Z-0958-2022 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.
