Atec Insignia Anterior Cervical Plate System Screw Blocking Mechanism Risk
The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems 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: FDA Class II defect in a cervical spine surgical implant where the screw blocking mechanism may fail to maintain fixation; however, no illnesses or injuries have been reported, making this a risk-of-harm product at the High severity level per the rubric.
Plain-English summary
The FDA is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0352, UDI: (01)00190376268576) manufactured by Alphatec Spine, Inc. This is a Class II medical device recall due to a potential defect in the screw blocking mechanism.
The screw blocking mechanism on the anterior cervical plate system may disassociate intraoperatively (during surgery) or postoperatively (after surgery), or unlock after the procedure. This defect could compromise the stability of the cervical spine surgical repair.
Affected units were distributed nationwide in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Four units with the device code 8609323R have been identified.
Healthcare facilities and patients who received this implant should contact Alphatec Spine, Inc. or their healthcare provider to discuss the potential risks and determine if any action is needed.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 4
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)
- 8609323R
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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