The Recall Desk
HighFDA (Devices)·Z-1822-2021·Announced 2021-06-16

Anterior Cervical Plate System Screw Mechanism Recall

Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.

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 medical device with potential mechanical failure of a critical surgical implant component. No illnesses or injuries reported. This qualifies as a risk-of-harm product where injury has not yet been documented, meeting the rubric criterion for 'High' severity.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0362, UDI: 00190376268620), a surgical implant used in anterior cervical fusion procedures. The recall affects 7 units distributed nationwide to facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

The recall was initiated because of a potential for the screw blocking mechanism on the anterior cervical plate to disassociate intraoperatively or postoperatively, or to unlock postoperatively. This mechanical failure could compromise the stability and proper function of the surgical implant.

Healthcare facilities and surgeons who received affected units (identified by lot code 8609328R) should contact Alphatec Spine, Inc. immediately for guidance. Patients implanted with affected units should consult their healthcare provider about potential monitoring or follow-up evaluations related to implant stability.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
  • implant-failure
  • 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)

  • 8609328R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category