Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0242) due to potential screw blocking 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 (2-level, 42mm) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts or moves improperly.
The screw blocking mechanism in the anterior cervical plate system could become disassociated or unlock after surgery. This might cause the plate to shift or move improperly, potentially leading to complications.
Patients who received the Atec Insignia Anterior Cervical Plate System (REF 136-0242) for spinal surgery are affected. Those with the specific model and size are most at risk.
Check for the product name 'Atec Insignia Anterior Cervical Plate System', model REF 136-0242, and size 42mm. The product is for spinal surgery only and non-sterile.
Patients should contact Alphatec directly for guidance on next steps.
The recall states there is a potential risk, but the product is not unsafe in normal use. Patients should contact Alphatec for specific guidance.
The model number is REF 136-0242 for the Atec Insignia Anterior Cervical Plate System.
Check for the product name 'Atec Insignia Anterior Cervical Plate System', model REF 136-0242, and size 42mm. The product is for spinal surgery only and non-sterile.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1812-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1812-2021 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.
