Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0118) due to potential screw mechanism disassociation 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 (REF 136-0118) because the screw blocking mechanism might become loose during or after surgery. This could lead to complications if the plate shifts.
The screw blocking mechanism in the anterior cervical plate system could become loose during or after surgery. This might cause the plate to shift, potentially leading to complications such as misalignment or instability in the spine.
Patients who received this specific spinal implant during surgery are affected. Those with the recalled model are at risk of complications if the screw mechanism becomes disassociated.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0118. The item was sold with specific UDI codes: (01)00190376268446; 8609303R and 8800403.
Reach out to Alphatec Spine, Inc. for specific instructions on the recalled product.
Yes, this recall applies to patients who received the Atec Insignia Anterior Cervical Plate System (REF 136-0118) during surgery.
Look for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0118 and UDI codes (01)00190376268446; 8609303R or 8800403.
Contact Alphatec Spine, Inc. for specific instructions on the recalled product.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1801-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1801-2021 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.
