Alphatec Recalls Trestle Luxe Anterior Cervical Plating System Components
Alphatec Spine is recalling 38 units of the Trestle Luxe Anterior Cervical Plating System because the Slide Alignment Tool does not fit the plate screws.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries were reported, and the defect is a mechanical fit issue rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
Alphatec Spine, Inc. is recalling 38 units of the Trestle Luxe Anterior Cervical Plating System, Product code KWQ. The recall involves specific lot numbers: 6629701, 6594701, 6434301, 6434302, and 6434302R1. The product was distributed nationwide.
The recall was initiated after Alphatec Spine received a complaint on May 9, 2012, reporting that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721) does not properly fit into the hexalobe screw on the Trestle Luxe Plate. The Trestle Luxe system is a temporary device used to stabilize the cervical spine during bone fusion development.
Healthcare providers and patients who have used or are using this specific device should contact Alphatec Spine for further instructions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and…
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
- Affected units
- 38
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 (5)
- Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701
- 6594701
- 6434301
- 6434302
- 6434302R1.
Distribution
Distributed nationwide across the United States.
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