FDA Device recall Z-1916-2025
LOWER EXTREMITY, Model: NCEX20I
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of LOWER EXTREMITY, Model: NCEX20I by American Contract Systems, citing 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 pos….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1916-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-21 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Model/UDI-DI/Lot(Expiration): NCEX20I/00191072222398/9146304(2025-12-03), 9207685(2026-01-08); NCEX20J/00191072234582/9…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1916-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.