Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
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 for a potential mechanical failure in an implanted surgical device. No injuries, deaths, or hospitalizations have been reported, making this a theoretical risk-of-harm scenario where injury has not yet been reported, which meets the High severity threshold.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0242), a medical device used in cervical spine surgery. The product includes 14 units distributed across 15 U.S. states.
The screw blocking mechanism on the anterior cervical plate may disassociate during surgery or unlock after surgery. This defect could affect the stability or function of the implant.
The affected product has codes 8663402R and 8609317R. Distribution was nationwide in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.
Healthcare providers and patients who may have been affected should contact Alphatec Spine, Inc. or consult their healthcare provider if they have concerns about their implant. The FDA's recall number is Z-1812-2021.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Affected units
- 14
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)
- 8663402R and 8609317R
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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