Z-1975-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,451 eaches
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Code Information
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;