Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0468) due to potential screw blocking mechanism disassociation post-surgery. Affected patients should contact 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 Atec Insignia Anterior Cervical Plate System (4-level, 68mm) because the screw mechanism might become loose after surgery. This could lead to complications if the plate shifts or fails to stay in place.
The screw blocking mechanism in the plate could become disassociated or unlock after surgery, potentially causing the plate to shift or fail to stay in place. This might lead to complications if the plate moves or doesn't function as intended.
Patients who have undergone spinal surgery using this specific plate system are most at risk. The recall applies to those with the 4-level, 68mm model purchased under the REF 136-0468 designation.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with the reference number 136-0468. The model is a 4-level, 68mm plate for surgical use only.
Reach out to Alphatec Spine, Inc. for guidance on next steps after identifying the recalled product.
Yes, the recall applies to patients who received the Atec Insignia Anterior Cervical Plate System (4-level, 68mm) during surgery.
Look for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0468, which is a 4-level, 68mm model for surgical use only.
Contact Alphatec Spine, Inc. directly for specific instructions on how to proceed with the recall.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1824-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1824-2021 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.
