Alphatec recalls its Atec Insignia Anterior Cervical Plate System (REF 136-0244) due to potential screw blocking mechanism disassociation during or 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 Atec Insignia Anterior Cervical Plate System (2-level, 44mm) 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 anterior cervical plate system could become unstable during or after surgery. If it disassociates, the plate might not stay properly aligned, potentially causing spinal issues.
Patients who received this specific spinal implant during surgery are most at risk. The recall applies to the Atec Insignia Anterior Cervical Plate System with the REF 136-0244 model.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with the REF 136-0244 model. This implant was used in surgeries for cervical spine procedures.
Reach out to Alphatec Spine, Inc. for specific instructions on how to handle the recalled implant.
The recall states there is a potential for the screw blocking mechanism to disassociate, but the exact risk level is not specified in the official notice.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with the REF 136-0244 model, which was used in cervical spine surgeries.
Contact Alphatec Spine, Inc. directly for guidance on next steps.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1813-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1813-2021 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.
