PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Sc...

FDA Device Recall #Z-0555-2014 — Class II — November 20, 2013

Recall Summary

Recall Number Z-0555-2014
Classification Class II — Moderate risk
Date Initiated November 20, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SpineFrontier, Inc.
Location Beverly, MA
Product Type Devices
Quantity 13

Product Description

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 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. .

Lot / Code Information

VM13222- 34489

Other Recalls from SpineFrontier, Inc.

Recall # Classification Product Date
Z-1973-2019 Class II A-CIFT SoloFuse Fixed Angle Driver, Model Numbe... Jun 13, 2019
Z-1479-2015 Class II SpineFrontier MISquito Percutaneous Pedicle S... Mar 5, 2015
Z-0977-2015 Class II lnline Persuader- PedFuse Pedicle Screw System;... Dec 19, 2014
Z-0576-2014 Class II Indus Invue Screws: IM71013-XX: Indus Screw04.0... Nov 20, 2013
Z-0554-2014 Class II PedFuse Reset Screw Inserters; PedFuse Screw In... Nov 20, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.