# FDA recall Z-1916-2025

> **American Contract Systems, Inc.** · Class II · device recall initiated 2025-04-21.

## Product

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

US Nationwide distribution in the state of CO.

## Key facts

- **Recall number:** Z-1916-2025
- **Recalling firm:** American Contract Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-21
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chandler, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1916-2025

## Citation

> AI Analytics. FDA recall Z-1916-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1916-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*