The Recall Desk
HighFDA (Devices)·Z-1799-2021·Announced 2021-06-16

Alphatec Insignia Anterior Cervical Plate System screw failure recalled

Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.

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 risk-of-harm medical device (spinal implant) with a potential mechanical failure of a critical component. No illnesses or injuries have been reported. Under the rubric, risk-of-harm products without reported injury receive a score of 3 (High).

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0116, Model Insignia ACP 1-Level 16mm), a device used in anterior cervical spine surgery.

The device's screw blocking mechanism has a potential to disassociate during surgery or unlock after surgery is complete. This mechanical failure could compromise the stability of the surgical fixation.

Approximately 8 units of this device were distributed nationwide to healthcare facilities in California, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Massachusetts, New Mexico, New York, North Carolina, Oklahoma, South Carolina, Texas, and Washington. The affected devices carry code 8609301R.

Patients who have received this implant should consult with their healthcare provider. Healthcare providers should contact Alphatec Spine, Inc. for additional information regarding this recall.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
  • screw-disassociation
  • 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)

  • 8609301R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category