The Recall Desk
HighFDA (Devices)·Z-1802-2021·Announced 2021-06-16

Alphatec Insignia Anterior Cervical Plate Screw Blocking Mechanism Disassociation Recall

Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after 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 a FDA Class II medical device recall involving a surgical spinal implant with a potential mechanical failure of the locking mechanism. The hazard could occur intraoperatively or postoperatively, posing risk to device stability. No injuries or hospitalizations have been reported in the source material.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (model REF 136-0119) due to a potential defect in the screw blocking mechanism. The mechanism may disassociate intraoperatively (during surgery) or postoperatively (after surgery), or unlock after surgery. This could compromise the stability and integrity of the surgical implant.

This recall affects 13 units that were distributed nationwide to medical facilities in the following states: 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 to discuss the potential risk and determine whether any monitoring or intervention is necessary. Healthcare providers should immediately cease use of the affected product and consult the manufacturer regarding patient management recommendations.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Spine / Orthopedic Implant
Hazard
Affected units
13

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)

  • 8609304R

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 29 recalled by Alphatec Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 29 products in this recall →

Related recalls

Same manufacturer · Alphatec Spine, Inc.

See all →

Same hazard · screw disassociation

See all →