The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1810-2021·Announced 2021-06-16

Anterior cervical plate system may lose screw locking mechanism during surgery

Alphatec Spine's Insignia Anterior Cervical Plate System may have a defective screw blocking mechanism that could disassociate during or after surgery. The FDA has recalled 19 units distributed across 15 US states.

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 of a surgical implant with potential for mechanical failure that could affect spinal stability. No illnesses or injuries are reported in the source text, and the hazard is identified as a potential risk rather than a confirmed failure. Per the rubric, this qualifies as High (Score 3): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (Reference 136-0238, Code 8609315R), an implant used to stabilize the cervical spine during neck surgery. Nineteen units have been recalled.

The screw blocking mechanism on this anterior cervical plate may disassociate during surgery, after surgery, or become unlocked following the procedure. If this occurs, the implant may fail to maintain proper spine stabilization.

The recalled devices were distributed nationwide across 15 states including 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 discuss the recall with their healthcare provider. Healthcare facilities should verify whether they have received recalled units and implement appropriate monitoring or follow-up protocols as advised by Alphatec Spine, Inc. or the FDA.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
19

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)

  • 8609315R

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 · mechanical failure

See all →

Similar recalls