The Recall Desk
HighFDA (Devices)·Z-1813-2021·Announced 2021-06-16

Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

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: FDA Class II recall for a surgical implant with a potential device malfunction (screw blocking mechanism disassociation/unlock). No illnesses or injuries reported to date. Per the rubric, this is a risk-of-harm medical device where injury has not yet been reported, placing it in the High category.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0244, codes 8663403R and 8609318R) due to a potential defect in the screw blocking mechanism. The mechanism may disassociate during surgery or after implantation, or unlock after surgery.

Three units were distributed nationwide to facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.

No injuries or adverse events have been reported. Patients and healthcare providers should be aware of this potential risk with the affected device.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Surgical Implant
Hazard
  • device-malfunction
  • implant-failure

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)

  • 8663403R & 8609318R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category