Z-1927-2013 Class II Terminated
FDA device recall Z-1927-2013 was initiated by SpineFrontier, Inc. on May 10, 2013 and is designated Class II. Reason for recall: Device design. The recall status is terminated (terminated Jul 20, 2015). Affected quantity: 12 devices.
Recall details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- May 10, 2013
- Termination Date
- Jul 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product description
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 split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Reason for recall
Device design.
Distribution pattern
Nationwide Distribution including Texas, Ohio, and Missouri.
Code information
Lot/Serial Numbers: 027104, 027105
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1927-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026