Alphatec Spine Recalls Mislabeled 14mm Trestle Luxe Cervical Screws
Alphatec Spine is recalling 14mm Trestle Luxe screws that were incorrectly labeled and laser-marked as 14mm but are actually 16mm.
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: This is a Class II recall involving a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Alphatec Spine, Inc. is recalling 4.0mm Variable Angle, Self-Drilling Hexalobe Screws, 14mm, from the Trestle Luxe Anterior Cervical Plating System. The recall involves 244 units in the US and 61 units outside the US.
During a field audit, an employee discovered that a 16mm Trestle Luxe Screw had been both laser marked and labeled as a 14mm Trestle Luxe Screw. The firm is recalling the affected lot codes to address this mislabeling.
The affected products were distributed worldwide, including to specific US states and countries such as Spain, Japan, Belgium, and Saudi Arabia. Healthcare providers and patients should verify the length of the screws against the labeling and contact Alphatec Spine for further instructions.
The recalled product
- Product
- 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V…
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
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)
- Part Number: 71240-14 Lot: 685904
Distribution
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