Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0119) 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 (REF 136-0119) because the screw blocking mechanism might disassociate or unlock 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 after surgery. This might cause the plate to disassociate or unlock, potentially leading to complications if the implant becomes loose.
Patients who received this spinal implant during surgery are affected. Those with the specific model and reference number are at risk.
Check for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0119. The product was sold under the specific model and size (1-Level, 19 mm) for medical use only.
Reach out to Alphatec Spine, Inc. for details about the recall and next steps.
The recall indicates a potential risk, so it is not recommended to use this specific model without consulting the manufacturer.
Check for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0119, and the specific model details (1-Level, 19 mm).
Contact Alphatec Spine, Inc. directly for guidance 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-1802-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1802-2021 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.
