FDA recall Z-1975-2025

Product

Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);

Reason for recall

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

Distribution

Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2025-05-07

Report date

2025-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Charlottesville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2025