Device product
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.
Z-0554-2014
Product summary
- Event
- Event 66873
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-0554-2014
Official wording
Reason: Screw inserters may not mate properly with hex interface of the screws.
Code information: VM 13194-34457
Distribution pattern: US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Derived failure modes
-
Unknown
Screw inserters may not mate properly with hex interface of the screws.