Alphatec recalls its Atec Insignia Anterior Cervical Plate System (REF 136-0356) due to potential screw mechanism disassociation after 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 Atec Insignia Anterior Cervical Plate System (3-level, 56mm) because the screw blocking mechanism might disassociate during or after surgery. This could lead to complications if the plate becomes unstable.
The screw blocking mechanism in the anterior cervical plate system may become unstable after surgery or during use. This could cause the plate to disassociate, potentially leading to spinal instability or complications.
Patients who received this spinal implant during surgery are affected. Those with the specific model and size are at risk of complications if the screw mechanism fails.
Check for the model number 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile. The product was sold with UDI: (01)00190376268590 or 8609325R.
Reach out to Alphatec Spine, Inc. for specific instructions on the recall.
Yes, this recall applies to patients who received the Atec Insignia Anterior Cervical Plate System during surgery.
Check for the model number 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile with UDI: (01)00190376268590 or 8609325R.
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-1819-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1819-2021 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.
