The Recall Desk
HighFDA (Devices)·Z-1823-2021·Announced 2021-06-16

Anterior cervical plate system screw mechanism may disassociate or unlock

The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a surgical implant with a structural defect in the screw locking mechanism. Per the severity rubric, FDA Class II recalls with structural defects require documented hospitalization or injury reports to reach Severe (4) rating. Since no injuries are documented in the source, this meets the High (3) criterion: a risk-of-harm medical device where injury has not yet been reported.

Plain-English summary

The FDA has issued a Class II recall of the Alphatec Insignia Anterior Cervical Plate System. The screw blocking mechanism may disassociate intraoperatively (during surgery) or postoperatively (after surgery), or unlock postoperatively (after surgery).

The affected product has reference number 136-0364 and code 8609329R. It has been distributed nationwide to hospitals and surgical facilities in multiple states including Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

Patients who have received this implant should contact their surgeon or healthcare provider to verify whether the affected device was implanted and determine next steps.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spine Implant
Hazard
  • screw-mechanism-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 8609329R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category