Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0478) 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, 78mm) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts during healing.
The screw blocking mechanism in the anterior cervical plate system could become disassociated or unlock after surgery. This might cause the plate to shift, potentially affecting spinal stability during healing.
Patients who received the recalled Insignia Anterior Cervical Plate System (4-level, 78mm) from Alphatec for spinal surgery are affected. Those with the specific model and reference number are at risk.
Check for the product name 'Insignia Anterior Cervical Plate System', model '4-Level, 78 mm', and reference number '136-0478'. The recall applies to patients who received this specific spinal implant during surgery.
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 postoperatively, but the exact risk level is not specified in the notice.
Look for the product name 'Insignia Anterior Cervical Plate System', model '4-Level, 78 mm', and reference number '136-0478' on your surgical implant.
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-1826-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1826-2021 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.
