Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0352) 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 Insignia Anterior Cervical Plate System (3-level, 52mm) because the screw blocking mechanism might disassociate during or after surgery. This could lead to complications if the plate becomes unstable after implantation.
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 securely in place, potentially causing movement or misalignment of the spine.
Patients who received the recalled Insignia Anterior Cervical Plate System (REF 136-0352) for spinal surgery are affected. Those with the specific model and size are most at risk.
Check for the product name 'Insignia Anterior Cervical Plate System' with model REF 136-0352. The item is a 3-level, 52mm spinal implant sold by Alphatec for prescription use only.
Patients should contact Alphatec directly to confirm if they have the recalled product and receive guidance on next steps.
No, this recall specifically applies to the Insignia Anterior Cervical Plate System with model REF 136-0352 (3-level, 52mm).
Contact Alphatec directly to confirm if you have the recalled product and receive guidance on next steps.
The recall states there is a potential for the screw mechanism to disassociate, which could lead to complications if the plate becomes unstable after surgery.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1817-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1817-2021 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.
