Alphatec recalls its Atec Insignia Anterior Cervical Plate System (REF 136-0117) 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 Atec Insignia Anterior Cervical Plate System (REF 136-0117) because the screw blocking mechanism might disassociate during or 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 during or after surgery. If it disassociates, the plate might not stay properly aligned, potentially causing spinal instability or complications.
Patients who received the recalled Atec Insignia Anterior Cervical Plate System (REF 136-0117) for spinal surgery are affected. Surgeons and medical staff using this product are at risk during procedures.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0117. The product was sold with specific identifiers: (01)00190376268439; 8663405R and 8800402.
Reach out to Alphatec directly for specific instructions on handling the recalled product.
The recall indicates a potential risk, so it is not recommended to use the product without consulting Alphatec.
Contact Alphatec directly for specific instructions on handling the recalled product.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0117 and identifiers (01)00190376268439; 8663405R and 8800402.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1800-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1800-2021 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.
