SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to labeling errors (mismarked/unmarked), which aligns with the 'Moderate' criteria for minor labeling errors.
Plain-English summary
SpineFrontier, Inc. is recalling Indus Invue Screws (IM71013-XX) used to secure the Invue Anterior Cervical Plate. The recall is being conducted because the screws were mismarked and unmarked.
The affected products were distributed nationwide, including the District of Columbia and the states of Ohio, Texas, Kansas, Massachusetts, Indiana, Colorado, New York, Alabama, and Michigan. The specific lot number for the recalled items is 0000.
Healthcare providers and patients should stop using the affected screws and contact SpineFrontier, Inc. for further instructions or a replacement.
The recalled product
- Product
- Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
- Manufacturer
- SpineFrontier, 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)
- Lot/Serial Number: IM71013-01: Lot 0000
Distribution
Part of a larger recall action
This product is one of 4 recalled by SpineFrontier, 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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