Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0250) 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 (2-level, 50mm) because the screw blocking mechanism might become disassociated or unlock after surgery. This could lead to complications if the plate shifts during healing.
The screw blocking mechanism in the anterior cervical plate system may become disassociated or unlock after surgery. This could cause the plate to shift, potentially leading to complications in spinal healing.
Patients who have undergone spinal surgery using this specific plate system are affected. Those with the 2-level, 50mm Insignia plate are at risk of complications if the screw mechanism disassociates.
Check for the product name 'Insignia Anterior Cervical Plate System' with the reference number 136-0250. This product was sold as a prescription-only item for spinal surgery.
Reach out to Alphatec Spine, Inc. for specific instructions on whether the plate system needs to be replaced or adjusted.
The recall states there is a potential for the screw mechanism to disassociate or unlock postoperatively, so it is not safe to use without manufacturer consultation.
Look for the product name 'Insignia Anterior Cervical Plate System' with reference number 136-0250, which was sold as a prescription-only item for spinal surgery.
The recall does not specify a stop-use instruction; contact Alphatec for guidance on whether the product needs to be replaced.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1815-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1815-2021 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.
