Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in a...

FDA Device Recall #Z-1869-2013 — Class II — October 5, 2012

Recall Summary

Recall Number Z-1869-2013
Classification Class II — Moderate risk
Date Initiated October 5, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SpineFrontier, Inc.
Location Beverly, MA
Product Type Devices
Quantity 11 caddies

Product Description

Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients

Reason for Recall

Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.

Distribution Pattern

US distribution in states of: CO, DC, MA and TX.

Lot / Code Information

31176, 018652, 018645R, 42011

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.