The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units
7

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.

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 →

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