SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling 993 Indus Invue screws used in cervical spine surgery because they are mismarked or unmarked.
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 identifies the issue as mismarked and unmarked screws without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving labeling errors or voluntary precautionary measures where harm has not been reported.
Plain-English summary
SpineFrontier, Inc. is recalling 993 units of Indus Invue Screws (IM71058-XX: 04.2mm, SelfTapping, Tapered). These medical devices are used to secure the Invue Anterior Cervical Plate in position during cervical spine surgery.
The recall was initiated because the affected screws are mismarked and unmarked. The specific lot numbers involved are IM71058-0l (Lot 0000), IM71058-02 (Lot 0000), and IM71058-03 (Lot 0000).
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 contact SpineFrontier, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 993
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 (3)
- Lot/Serial Number: IM71058-0l: Lot 0000
- IM71058-02: Lot 0000
- IM71058-03 : 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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