Z-0553-2014 Class II Terminated
FDA device recall Z-0553-2014 was initiated by SpineFrontier, Inc. on November 20, 2013 and is designated Class II. Reason for recall: Screw inserters may not mate properly with hex interface of the screws. The recall status is terminated (terminated June 26, 2018). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2014
- Initiation Date
- November 20, 2013
- Termination Date
- June 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Reason for Recall
Screw inserters may not mate properly with hex interface of the screws.
Distribution Pattern
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Code Information
VM13221-34457