Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0474) due to potential screw mechanism disassociation post-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 (4-level, 74mm) because the screw blocking mechanism might disassociate during or after surgery. This could lead to complications if the plate becomes unstable after implantation.
The screw blocking mechanism in the anterior cervical plate system could become disassociated or unlock after surgery. This might cause the plate to become unstable, potentially leading to complications if the spinal structure is no longer properly supported.
Patients who received the recalled Insignia Anterior Cervical Plate System (REF 136-0474) from Alphatec. Surgeons and medical staff who used this specific model during procedures are also at risk.
Check for the product name 'Insignia Anterior Cervical Plate System' with the reference number 136-0474. The product was sold with the unique identifiers (01)00190376268699 and 8609333R.
Reach out to Alphatec Spine, Inc. for specific guidance on the recalled product and next steps.
The recall states there is a potential for the screw mechanism to disassociate postoperatively, so it is not recommended for use without manufacturer consultation.
Contact Alphatec Spine, Inc. directly for details on the recall and necessary actions.
Look for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0474 and unique identifiers (01)00190376268699 or 8609333R.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1825-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1825-2021 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.
