The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the...

FDA Device Recall #Z-1216-2018 — Class II — October 16, 2017

Recall Summary

Recall Number Z-1216-2018
Classification Class II — Moderate risk
Date Initiated October 16, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Instruments Div. of Stryker Corporation
Location Portage, MI
Product Type Devices
Quantity 28

Product Description

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.

Reason for Recall

Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.

Distribution Pattern

International , US and US Govt.

Lot / Code Information

Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824

Other Recalls from Stryker Instruments Div. of Stryker C...

Recall # Classification Product Date
Z-1452-2022 Class II SurgiCount+ System Application, Software Versio... Jun 15, 2022
Z-0431-2021 Class II Stryker Zyphr Disposable Cranial Perforator, La... Oct 16, 2020
Z-1807-2020 Class II Neptune E-SEP 165mm Blade Electrode, Catalog Nu... Mar 26, 2020
Z-1402-2022 Class II Triton Canister System (finished part numbers F... Jan 22, 2020
Z-1097-2020 Class II SafeAir Telescopic Smoke Evacuation Pencil, Pr... Jan 13, 2020

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.