Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0234) due to potential screw mechanism disassociation post-surgery. Affected patients should contact 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, 34mm) because the screw blocking mechanism might disassociate during or after surgery. This could lead to complications if the plate becomes unstable.
The screw blocking mechanism in the plate could become loose or disengage during or after surgery. This might cause the plate to become unstable, potentially leading to complications like misalignment or additional surgical intervention.
Patients who received the recalled Atec Insignia Anterior Cervical Plate System (REF 136-0234) for cervical spine surgery are affected. Surgeons and medical staff using this specific implant are at highest risk.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0234. The product was sold with specific identifiers: (01)00190376268378; 8609313R and 8800410.
Reach out to Alphatec Spine, Inc. for guidance on next steps regarding the recalled implant.
This recall affects patients who received the specific Atec Insignia Anterior Cervical Plate System (REF 136-0234) for cervical spine surgery. Surgeons and medical staff using this implant are also at risk.
The recalled product is the Atec Insignia Anterior Cervical Plate System with reference number 136-0234 (2-level, 34mm).
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0234. The product was sold with specific identifiers: (01)00190376268378; 8609313R and 8800410.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1808-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1808-2021 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.
