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);
Reported: June 18, 2025 Initiated: May 7, 2025 #Z-1975-2025
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.
Details
- Recalling Firm
- MicroAire Surgical Instruments, LLC
- Units Affected
- 1,451 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
- Location
- Charlottesville, VA
Frequently Asked Questions
What product was recalled? ▼
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);. Recalled by MicroAire Surgical Instruments, LLC. Units affected: 1,451 eaches.
Why was this product recalled? ▼
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1975-2025.
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