The Recall Desk
HighFDA (Devices)·Z-1818-2021·Announced 2021-06-16

Alphatec Insignia Anterior Cervical Plate: Screw Blocking Mechanism May Disassociate

Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during or after spinal surgery.

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: This is an FDA Class II medical device recall with no reported injuries or deaths. The hazard is a potential mechanical failure of the screw blocking mechanism, classified as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.

Plain-English summary

Alphatec Spine, Inc. is recalling the Insignia Anterior Cervical Plate System (REF 136-0354, UDI: 00190376268583) due to a potential malfunction of the screw blocking mechanism. The mechanism may disassociate during surgery (intraoperatively) or after surgery (postoperatively), or may unlock after surgery. Approximately 7 units of this device have been identified for recall.

The recalled device has been distributed nationwide in 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 device should contact their surgeon or healthcare provider to discuss whether they may be affected and what monitoring or follow-up care may be appropriate. Healthcare providers should immediately check their inventory for any affected units and contact Alphatec Spine for instructions regarding returns or replacement.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant System
Hazard
  • mechanism-failure
  • lock-disassociation

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)

  • 8609324R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category