Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0121) due to potential screw mechanism disassociation post-surgery. Affected patients should contact 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 Atec Insignia Anterior Cervical Plate System (REF 136-0121) 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 anterior cervical plate system may become disassociated or unlock after surgery. This could cause the plate to shift, potentially leading to complications in spinal healing.
Patients who received this spinal implant during surgery are affected. Those with the specific model and reference number are most at risk.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0121. This was sold for surgical use only.
Reach out to Alphatec Spine, Inc. for specific guidance on the recall and next steps.
The recall indicates a potential risk, so it is not recommended for use without manufacturer consultation.
Look for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0121, which was used for surgical procedures only.
Contact Alphatec Spine, Inc. directly for instructions on the recall and necessary actions.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1804-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1804-2021 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.
