Alphatec recalls Insignia Anterior Cervical Plate System (REF 136-0124) due to potential screw mechanism disassociation post-surgery. Affected patients should contact Alphatec for details.
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 Insignia Anterior Cervical Plate System (REF 136-0124) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts during healing.
The screw blocking mechanism in the cervical plate system could become disassociated or unlock after surgery. This might cause the plate to shift, potentially affecting spinal stability during healing.
Patients who received the Insignia Anterior Cervical Plate System (REF 136-0124) for spinal surgery are affected. Patients with this specific implant are most at risk.
Check for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0124. This was sold for spinal surgery only (Rx Only) and is non-sterile.
Reach out to Alphatec directly for specific instructions on the recall and next steps.
The recall indicates a potential risk, but the product is not unsafe for all users. Patients with this specific implant should follow the recall instructions.
Contact Alphatec directly for details on the recall and next steps.
The recall does not mention a fix; patients should contact Alphatec 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-1806-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1806-2021 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.