Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0360) due to potential screw mechanism disassociation post-surgery. Affected patients should contact the company 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 Insignia Anterior Cervical Plate System (3-level, 60mm) because the screw blocking mechanism might disassociate or unlock after surgery. This could lead to complications if the plate becomes unstable.
The screw blocking mechanism in the cervical plate system may become unstable after surgery or during the procedure. If it disassociates or unlocks, the plate could shift, potentially causing instability in the spine.
Patients who received the recalled Insignia Anterior Cervical Plate System (REF 136-0360) for spinal surgery are affected. Surgeons and medical staff using this product are at higher risk during procedures.
Check for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0360. The product was sold with specific identifiers: (01)00190376268613 and 8609327R.
Reach out to Alphatec Spine, Inc. for guidance on the recall and next steps.
The recall indicates a potential risk, so it is not recommended for use without contacting Alphatec for guidance.
Contact Alphatec Spine, Inc. directly for instructions on the recall process.
Look for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0360 and identifiers (01)00190376268613 or 8609327R.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1821-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1821-2021 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.
