Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0122) 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 (REF 136-0122) 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 disassociated or unlock after surgery. This might cause the plate to shift, potentially leading to complications.
Patients who received this specific spinal implant during surgery are affected. Those with the 1-Level, 22 mm Insignia ACP system are most at risk.
Check for the product name 'Insignia Anterior Cervical Plate System', model REF 136-0122, and the unique identifier (01)00190376268484 or 8609307R. This implant is used for spinal surgery only.
Reach out to Alphatec directly for guidance on next steps after recalling your implant.
The recall indicates a potential risk, so it is not safe to use without contacting Alphatec first.
Contact Alphatec directly for guidance on next steps after recalling your implant.
Check for the product name 'Insignia Anterior Cervical Plate System', model REF 136-0122, and the unique identifier (01)00190376268484 or 8609307R.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1805-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1805-2021 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.
