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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 18
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
Part of a larger recall action
This product is one of 29 recalled by Alphatec Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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