Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0240) due to potential screw blocking mechanism disassociation post-surgery. Affected patients should contact for guidance.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Alphatec is recalling its Atec Insignia Anterior Cervical Plate System (2-level, 40mm) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts or becomes unstable.
The screw blocking mechanism in the anterior cervical plate system may disassociate or unlock after surgery. This could cause the plate to shift or become unstable, potentially leading to complications.
Patients who received this spinal implant during surgery are affected. Surgeons and medical staff who used this product are most at risk.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0240. This was sold for prescription use only.
Reach out to Alphatec Spine, Inc. for guidance on next steps after recalling the product.
The recall indicates a potential risk, so it is not safe to use without manufacturer guidance.
Look for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0240.
Contact Alphatec Spine, Inc. for specific instructions.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1811-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1811-2021 from Alphatec. 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.
