Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0362) due to potential screw blocking 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, 62mm) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts during healing.
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 affecting spinal stability and healing.
Patients who received this spinal implant during surgery are affected. Those with the specific model number and reference code are most at risk.
Check for the model number REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile. The unique device identifier (UDI) is (01)00190376268620 or 8609328R.
Reach out to Alphatec directly for guidance on next steps after identifying the recalled product.
No, this recall specifically applies to the Insignia Anterior Cervical Plate System with model REF 136-0362.
Check for the model number REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, and the unique device identifier (UDI) (01)00190376268620 or 8609328R.
Contact Alphatec directly for guidance on next steps after identifying the recalled product.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1822-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1822-2021 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.
