The Recall Desk
HighFDA (Devices)·Z-1807-2021·Announced 2021-06-16

Atec Insignia Anterior Cervical Plate System Recalled for Potential Screw Failure

Alphatec Spine recalled the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism, which could disassociate 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: The device is FDA Class II with no reported illnesses or injuries. However, it is a surgical implant with a structural defect (screw mechanism failure) that poses a risk of harm during or after surgery. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).

Plain-English summary

The Atec Insignia Anterior Cervical Plate System, manufactured by Alphatec Spine Inc., is a surgical implant used in cervical spine fusion procedures. The manufacturer has recalled this device because the screw blocking mechanism may potentially disassociate or unlock.

The mechanism may disassociate or unlock during the surgical procedure (intraoperatively) or after the procedure (postoperatively). Such failure could affect the stability of the implant.

The recalled product was distributed nationwide to medical facilities in the following 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Three units were distributed under model REF 136-0232 with lot code 8609312R.

Patients who have received this implant should consult their healthcare provider with any questions or concerns about their implant in light of this recall.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant / Orthopedic
Hazard
  • implant-failure
  • screw-loosening
  • intraoperative-risk

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)

  • 8609312R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category