The Recall Desk
HighFDA (Devices)·Z-1824-2021·Announced 2021-06-16

Alphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk

Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate 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 an FDA Class II recall of a surgical implant with a potential mechanism failure where the screw blocking system may disassociate during or after surgery. No illnesses or injuries have been reported, placing it in the High category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Alphatec Spine, Inc. is recalling the Insignia Anterior Cervical Plate System, a surgical implant used in cervical spine procedures. The specific recalled product reference is REF 136-0468 (code 8609331R), and 2 units have been distributed.

The FDA has determined there is a potential for the screw blocking mechanism to disassociate during surgery (intraoperatively) or unlock after surgery (postoperatively). This defect could compromise the stability of the implant.

The recalled units were distributed to medical facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Healthcare providers and patients who have received this implant should contact Alphatec Spine or their healthcare provider for additional information and guidance.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
2

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)

  • 8609331R

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.

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Same hazard · implant failure

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