LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK...

FDA Device Recall #Z-1916-2025 — Class II — April 21, 2025

Recall Summary

Recall Number Z-1916-2025
Classification Class II — Moderate risk
Date Initiated April 21, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm American Contract Systems, Inc.
Location Chandler, AZ
Product Type Devices
Quantity 850 Kits

Product Description

LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS

Reason for Recall

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

Distribution Pattern

US Nationwide distribution in the state of CO.

Lot / Code Information

Model/UDI-DI/Lot(Expiration): NCEX20I/00191072222398/9146304(2025-12-03), 9207685(2026-01-08); NCEX20J/00191072234582/9222096(2026-01-30), 9222096(2026-01-30); NCTK31K/00191072222480/9086225(2025-11-01), 9086225(2025-11-01); NCTK31L/00191072234872/9219596(2026-01-15), 9219596(2026-01-15)

Other Recalls from American Contract Systems, Inc.

Recall # Classification Product Date
Z-1426-2025 Class II Brand Name: Banner University Med Ctr. Produ... Jan 31, 2025
Z-1425-2025 Class II Brand Name: Banner Health Systems Product Name... Jan 31, 2025
Z-1424-2025 Class II Brand Name: Banner Health Systems Product Name... Jan 31, 2025
Z-3244-2024 Class II Pacemaker, COPM11B; Medical convenience kit Aug 7, 2024
Z-3238-2024 Class II Vaginal Delivery, ASDV25B; Medical convenience kit Aug 7, 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.