The Recall Desk
HighFDA (Devices)·Z-1809-2021·Announced 2021-06-16

Anterior cervical plate system screw blocking mechanism may disassociate

Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries 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: This is an FDA Class II medical device recall with no reported injuries or illnesses. However, it describes a potential structural failure of a critical spinal implant where mechanical failure during or after surgery could cause serious patient harm, qualifying it as a high-risk product with unrealized injury risk.

Plain-English summary

Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0236, code 8609314R, UDI 01-00190376268385). The device is used in anterior cervical fusion surgery. A total of 18 units have been recalled.

The screw blocking mechanism on the plate may disassociate intraoperatively (during surgery) or unlock postoperatively (after surgery). This potential failure could compromise the stability of the implant during or after the surgical procedure.

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

Healthcare providers who have received this device should immediately discontinue use and contact Alphatec Spine, Inc. for replacement or further instructions. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Spinal implant
Hazard
  • implant-failure
  • screw-unlock

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)

  • 8609314R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category