FDA recall Z-1916-2025

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

Status

Ongoing

Initiation date

2025-04-21

Report date

2025-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chandler, AZ, United States

Primary source

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