Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0236) 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, 36mm) because the screw blocking mechanism might become disassociated or unlock after surgery. This could lead to complications if the plate no longer stays securely in place.
The screw blocking mechanism in the anterior cervical plate system could become disassociated or unlock after surgery. This might cause the plate to become loose, potentially leading to instability in the cervical spine.
Patients who received this spinal implant during surgery are most at risk. The recall applies to specific model numbers and sizes used in cervical spine procedures.
Check for the model number REF 136-0236 on the product label. The system is a 2-level, 36mm cervical plate used in non-sterile surgical procedures.
Patients should contact Alphatec directly for guidance on next steps after receiving the recall notice.
No, this recall specifically applies to the Atec Insignia Anterior Cervical Plate System with model number REF 136-0236.
Contact Alphatec directly for guidance on next steps after receiving the recall notice.
The recall does not specify that the implant must be removed immediately; patients should contact Alphatec for further instructions.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1809-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1809-2021 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.
