Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0238) due to potential screw mechanism disassociation post-surgery. Affected patients should contact Alphatec 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, 38mm) 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 may disassociate or unlock after surgery. This could cause the plate to shift, potentially affecting spinal stability during healing.
Patients who received this spinal implant during surgery are affected. Those with the specific model number (REF 136-0238) are most at risk.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with model REF 136-0238. This was sold as a prescription-only implant for spinal surgery.
Reach out to Alphatec Spine, Inc. for guidance on next steps after identifying the recalled product.
The recall indicates a potential risk, but the product is not unsafe for normal use. Patients should follow the manufacturer's guidance.
Look for the product name 'Atec Insignia Anterior Cervical Plate System' with model REF 136-0238, which was sold as a prescription-only implant for spinal surgery.
Contact Alphatec Spine, Inc. for specific instructions based on your situation.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1810-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1810-2021 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.
