Z-0554-2014 Class II Terminated
FDA device recall Z-0554-2014 was initiated by SpineFrontier, Inc. on Nov 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 Jun 26, 2018). Affected quantity: 25.
Recall details
- Product Type
- Devices
- Report Date
- Jan 1, 2014
- Initiation Date
- Nov 20, 2013
- Termination Date
- Jun 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product description
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 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
VM 13194-34457
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0554-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026