Atec Insignia Cervical Plate Screw Locking Mechanism May Fail
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism that could cause separation during or after surgery.
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 a risk-of-harm product (surgical implant with mechanical failure potential) where injury has not yet been reported in the source text. Although FDA Class II, without reported hospitalizations or injuries and with a theoretical hazard, the severity is limited to High per the rubric.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (Model 136-0478, 4-Level, 78 mm). This is a surgical implant used in cervical spine operations.
The screw blocking mechanism on this anterior cervical plate has the potential to disassociate during surgery or to unlock after surgery. If this occurs, the plate may no longer provide proper support to the cervical spine, potentially compromising the surgical repair.
The device was distributed nationwide to surgical facilities. Healthcare providers and patients who have received this implant should be aware of this risk and consult with their physician regarding monitoring or management options.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- locking-mechanism-failure
- device-disassociation
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)
- 8609334R
Distribution
Distributed nationwide across the United States.
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