Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0482) due to potential screw mechanism disassociation post-surgery. Affected patients should contact Alphatec 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 (4-level, 82mm) because the screw blocking mechanism might become loose after surgery. This could lead to the plate shifting, which may cause pain or complications if not addressed.
The screw blocking mechanism in the anterior cervical plate system could become disassociated or unlock after surgery. This might cause the plate to shift, potentially leading to pain or complications if not corrected.
Patients who have undergone spinal surgery using this specific plate system are affected. Those with the 4-level, 82mm model are most at risk.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with model REF 136-0482. The product is 4-level, 82mm, and requires a prescription (Rx Only).
Patients should contact Alphatec directly for guidance on next steps after recalling the product.
The recall indicates a potential risk, so patients should not use the product without consulting Alphatec first.
Look for the product name 'Atec Insignia Anterior Cervical Plate System' with model REF 136-0482, 4-level, 82mm, and Rx Only.
Contact Alphatec directly for guidance on next steps after recalling the product.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1827-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1827-2021 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.
