Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component...

FDA Device Recall #Z-0111-2015 — Class II — September 30, 2014

Recall Summary

Recall Number Z-0111-2015
Classification Class II — Moderate risk
Date Initiated September 30, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Signal Medical Corporation
Location Marysville, MI
Product Type Devices
Quantity 41

Product Description

Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).

Reason for Recall

Packaging of a device was compromised

Distribution Pattern

Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.

Lot / Code Information

Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L Catalog # 22-01-02004, Serial # l0358, Size 4L Catalog # 22-01-02005, Serial # L0809; Size 5L Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R

Other Recalls from Signal Medical Corporation

Recall # Classification Product Date
Z-1834-2017 Class II Soft Face "No Bounce" Mallet Model/Catalog: BI... Feb 20, 2017
Z-0109-2015 Class II Microseal Augmented (20 degrees) Liner, acetabu... Sep 23, 2014

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.