Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0354) due to potential screw mechanism disassociation post-surgery. Affected patients should contact the company 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, 54mm) 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 might disassociate or unlock after surgery. This could cause the plate to shift, potentially leading to complications in spinal healing.
Patients who received this spinal implant during surgery are most at risk. The recall applies to specific models sold with a unique identifier.
Check for the model number 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile. The unique identifier (UDI) is (01)00190376268583 or 8609324R.
Reach out to Alphatec Spine, Inc. for specific instructions on the recall.
Yes, this recall applies to patients who received the Insignia Anterior Cervical Plate System during surgery.
Check for the model number 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile with UDI (01)00190376268583 or 8609324R.
Contact Alphatec Spine, Inc. for specific instructions on 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-1818-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1818-2021 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.
