Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure
Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been 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: FDA Class II recall for a surgical implant with a potential device malfunction (screw blocking mechanism disassociation/unlock). No illnesses or injuries reported to date. Per the rubric, this is a risk-of-harm medical device where injury has not yet been reported, placing it in the High category.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0244, codes 8663403R and 8609318R) due to a potential defect in the screw blocking mechanism. The mechanism may disassociate during surgery or after implantation, or unlock after surgery.
Three units were distributed nationwide to facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.
No injuries or adverse events have been reported. Patients and healthcare providers should be aware of this potential risk with the affected device.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 3
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)
- 8663403R & 8609318R
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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