Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0248) due to potential screw blocking mechanism disassociation post-surgery. Affected patients should contact for remedy.
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 (2-level, 48mm) because the screw blocking mechanism might become loose after surgery. This could lead to complications if the device shifts during healing.
The screw blocking mechanism in the anterior cervical plate system could become disassociated or unlock after surgery. This might cause the device to shift, potentially affecting spinal stability during healing.
Patients who received this spinal implant during surgery are affected. Those with the specific model and size are most at risk.
Check for the model number 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile. The device was sold with UDI numbers (01)00190376268521; 8609319R and 8663404R.
Reach out to Alphatec Spine, Inc. for instructions on the remedy for the recalled spinal implant.
No, this recall specifically applies to the Atec Insignia Anterior Cervical Plate System (2-level, 48mm) with the model number 136-0248.
Contact Alphatec Spine, Inc. for instructions on the remedy as the recall does not specify a direct action like discarding or returning.
The recall states a potential for the screw blocking mechanism to disassociate or unlock postoperatively, which could affect spinal stability but does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1814-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1814-2021 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.
