SpineFrontier Recalls Invue Split Driver Devices Due to Design Flaw
SpineFrontier, Inc. is voluntarily recalling 12 Invue Split Driver devices due to a device design issue. The recall covers units distributed nationwide.
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 source text does not report any injuries, illnesses, or deaths, and the hazard is described generally as a design issue without specific injury reports, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
SpineFrontier, Inc. is voluntarily recalling 12 units of the Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. The recall was initiated on May 10, 2013, and was classified as Class II by the FDA. The reason for the recall is cited as a device design issue.
The affected devices are used in conjunction with the Invue Anterior Cervical Plate System. The specific lot/serial numbers involved are 027104 and 027105. The devices were distributed nationwide, including in Texas, Ohio, and Missouri.
The recall status is terminated as of July 20, 2015. No specific instructions for consumers are provided in the source text, but the recall was initiated by the firm via email notification.
The recalled product
- Product
- Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 12
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 Numbers: 027104
- 027105
Distribution
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