GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

FDA Device Recall #Z-0566-2023 — Class II — November 3, 2022

Recall Summary

Recall Number Z-0566-2023
Classification Class II — Moderate risk
Date Initiated November 3, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DeRoyal Industries Inc
Location Powell, TN
Product Type Devices
Quantity 4 units

Product Description

GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

Reason for Recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Distribution Pattern

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Lot / Code Information

Lot Numbers: Lot 56822290 exp 2/1/2025

Other Recalls from DeRoyal Industries Inc

Recall # Classification Product Date
Z-1291-2025 Class II DeRoyal REF 71-C5100NS Tubing, Suction, Connect... Jan 31, 2025
Z-1174-2025 Class II DeRoyal AMG Suction Connector Tubing REF: 71-2... Jan 15, 2025
Z-0306-2025 Class II DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 Oct 3, 2024
Z-0307-2025 Class II DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-93... Oct 3, 2024
Z-0308-2025 Class II DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-934... Oct 3, 2024

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.