Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0554-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2013-11-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0554-2014
Date of alert
2013-11-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SpineFrontier, Inc.
Product category
device
Product type
Devices
Reported risk: Screw inserters may not mate properly with hex interface of the screws.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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