SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.
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. The hazard is a labeling defect (mismarked/unmarked) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
SpineFrontier, Inc. is recalling Indus Invue Screws (IM71016-XX: 04.5mm, SelfTapping) because some units are mismarked or unmarked. These medical devices are used to secure the Invue Anterior Cervical Plate in position.
The recall covers lots 0000 and 0001 of the IM71 0 16-01 series. The products were distributed nationwide, including the District of Columbia and the states of Ohio, Texas, Kansas, Massachusetts, Indiana, Colorado, New York, Alabama, and Michigan.
Healthcare providers and patients should stop using these specific screws and contact SpineFrontier, Inc. for further instructions or replacement. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. 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 (2)
- Lot/Serial Number: IM71 0 16-01: Lots 0000
- 000 1
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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