1.8mm Truss Wire Component Recalled for Product Upgrade
New Standard Device Inc is recalling 1.8mm truss wires used in the Metalogix Revolution External Plating System to facilitate introduction of stronger 2.0mm wires.
What this means for you
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 with no reported product failures, injuries, or illnesses mentioned in the source. The recall appears to be a proactive product upgrade rather than a response to documented safety problems, fitting the profile of a voluntary precautionary recall.
Plain-English summary
New Standard Device Inc is recalling the 1.8mm Truss Wire (REF: 900217), a component of the Metalogix Revolution External Plating System. Approximately 426 units were distributed nationwide to facilities in Arizona, Virginia, Ohio, Connecticut, Texas, North Carolina, and Georgia.
The recall is being conducted to facilitate introduction of 2.0mm truss wires, which the manufacturer states will provide improved strength and reduced breakage through an increased wire diameter and new manufacturing process.
Patients and healthcare providers who have devices with the recalled 1.8mm truss wires should contact New Standard Device Inc for further guidance. Additional information is available from the FDA or the agency's recall database.
The recalled product
- Product
- 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
- Manufacturer
- New Standard Device Inc
- Hazard
- wire-breakage
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 (2)
- UDI: 854641008419
- Lots: A29518X and A17219DA
Distribution
Distributed nationwide across the United States.
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