Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0364) due to potential screw mechanism disassociation after surgery. Affected patients should contact the manufacturer 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 (3-level, 64mm) because the screw blocking mechanism might become loose or unlock 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 'Insignia Anterior Cervical Plate System', model REF 136-0364, and the unique identifiers (01)00190376268637 or 8609329R. This product was used only with a prescription.
Reach out to Alphatec Spine, Inc. for specific instructions about the recalled product.
The recall states there is a potential for the screw mechanism to disassociate or unlock after surgery, so it is not safe to use without manufacturer consultation.
Look for the product name 'Insignia Anterior Cervical Plate System', model REF 136-0364, and unique identifiers (01)00190376268637 or 8609329R.
Contact Alphatec Spine, Inc. for specific instructions about the recalled product.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1823-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1823-2021 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.
