The Recall Desk
HighFDA (Devices)·Z-1827-2021·Announced 2021-06-16

Anterior cervical plate system screw blocking mechanism defect recalled

Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that 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: FDA Class II medical device with potential for serious surgical complications including implant failure requiring revision surgery, but no reported injuries or deaths. The hazard is theoretical without confirmed incidents.

Plain-English summary

The Atec Insignia Anterior Cervical Plate System (REF 136-0482, UDI: (01)00190376268712) manufactured by Alphatec Spine, Inc. has been recalled due to a defect in the screw blocking mechanism.

The screw blocking mechanism can disassociate intraoperatively (during surgery) or postoperatively (after surgery), or unlock after the procedure. This could result in improper plate positioning or screw loosening, potentially requiring revision surgery or causing complications.

The affected product has been distributed nationwide across 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. The lot code is 8609335R.

Patients or healthcare providers who have this device should contact Alphatec Spine, Inc. for guidance. Do not use recalled units. Healthcare facilities should review inventory and quarantine affected units.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Implant - Spine
Hazard
  • screw-failure
  • device-malfunction

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)

  • 8609335R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category