Alphatec recalls Insignia Anterior Cervical Plate System (REF 136-0116) due to potential screw mechanism disassociation post-surgery. Affected patients should contact Alphatec 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 136-0116) because the screw blocking mechanism might become loose after surgery or during surgery. This could lead to improper spinal alignment or complications.
The screw blocking mechanism in the cervical plate system could become disassociated during or after surgery. This might cause the plate to become unstable, potentially leading to improper spinal alignment or complications.
Patients who received this specific spinal implant during surgery are affected. Those with the 1-Level, 16 mm Insignia ACP system are most at risk.
Check for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0116. The item was sold as a prescription-only spinal implant.
Patients should contact Alphatec directly to confirm if they have the recalled product and receive instructions.
The recall indicates a potential risk, but the product is not unsafe in normal use. Patients should contact Alphatec for specific guidance.
Contact Alphatec directly to confirm if you have the recalled product and receive instructions.
Look for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0116. The item was sold as a prescription-only spinal implant.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1799-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1799-2021 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.
