The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1800-2021·Announced 2021-06-16

Atec Insignia Anterior Cervical Plate System screw mechanism failure

Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate or unlock during or after spine surgery, potentially compromising implant stability.

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 recall involving a surgical implant with a structural defect that could compromise implant stability. No illnesses or injuries have been reported. Under the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0117, UDI: (01)00190376268439) due to a potential defect in the screw blocking mechanism. The screw blocking mechanism may disassociate during surgery, remain disassociated after surgery, or unlock after surgery, which could compromise the stability of the implant.

The recalled product was distributed nationwide to healthcare facilities across 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Affected product code numbers are 8663405R and 8800402.

This is an FDA Class II recall.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implants
Hazard
Affected units
6

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)

  • 8663405R and 8800402

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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