MicroAire Surgical Instruments, LLC: Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Bl

Hazard

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

Details from the source

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. Quantity: 1,451 eaches Lot/code info: Catalog (SKU) Numbers:(1) 83030-1 (single pack), (2) 83030-6 (six pack) and (3) 83030-6-CE (six pack OUS only); UDI-DI: (1) 00847399017246 (single pack), (2&3) 00847399015860 (six pack); Lot Numbers: (1) 104842032025, (2) 104841032025, 104873032025, 104885042025, 104902042025, (3) 104865032025;

UPC codes

00847399017246, 00847399015860, 104842032025, 104841032025, 104873032025, 104885042025, 104902042025, 104865032025

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.