The Recall Desk
HighFDA (Devices)·Z-1804-2021·Announced 2021-06-16

Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock 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 a Class II medical device recall involving a potential structural defect in a surgical implant. While no reported illnesses or injuries have been documented, the hazard presents a risk of serious harm if the screw mechanism were to fail in a critical anatomical location.

Plain-English summary

Alphatec Spine, Inc. is recalling 7 units of the Atec Insignia Anterior Cervical Plate System, REF 136-0121 (1-Level, 21 mm, Code 8609306R).

There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively or postoperatively, or to unlock postoperatively.

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

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant / Orthopedic
Hazard
  • screw-disassociation
  • device-failure
  • surgical-implant-defect

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)

  • 8609306R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category