Alphatec recalls its Insignia Anterior Cervical Plate System (REF 136-0232) 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, 32mm) 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 could become disassociated or unlock after surgery. This might cause the plate to shift, potentially affecting spinal stability and healing.
Patients who received this spinal implant during surgery are most at risk. The recall applies to the specific model and size used in the procedure.
Check for the product name 'Insignia Anterior Cervical Plate System' with model REF 136-0232. The device is used in spinal surgeries and is non-sterile.
Reach out to Alphatec Spine, Inc. for specific recall instructions and to confirm if your implant is affected.
No, this recall specifically applies to the Insignia Anterior Cervical Plate System (REF 136-0232) used in certain spinal surgeries.
The recall does not specify a stop-use instruction; affected patients should contact Alphatec for guidance.
Look for the product name 'Insignia Anterior Cervical Plate System' with model REF 136-0232, which is used in non-sterile spinal surgeries.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1807-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1807-2021 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.
