Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0350) due to potential screw mechanism disassociation post-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 Insignia Anterior Cervical Plate System (3-level, 50mm) 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 plate could become loose or disengage after surgery, potentially causing the plate to become unstable. This might lead to complications such as misalignment or improper spinal support.
Patients who received this specific spinal implant during surgery are affected. Those with the 3-level, 50mm Insignia plate are most at risk.
Check if your spinal implant has the model number REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile. The unique device identifier (UDI) listed is (01)00190376268569 or 8609322R.
Reach out to Alphatec Spine, Inc. for specific guidance on your implant model and next steps.
No, this recall specifically applies to the Insignia Anterior Cervical Plate System with model REF 136-0350 (3-level, 50mm).
Contact Alphatec Spine, Inc. directly for details about your specific implant and recommended actions.
The recall states there is a potential for the screw mechanism to disassociate, which could lead to complications, but the exact risk level is not specified in the notice.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1816-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1816-2021 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.
