Olympus Corporation of the Americas: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Nu

Hazard

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Details from the source

Reason for recall: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Hon Quantity: 34,325 units (13267 US, 21058 OUS) Lot/code info: Model: TB-0545FCS; Catalog Number/Product Code: R5000688; UDI: 04953170409684, 04953170383519; Lots: All;

UPC codes

04953170409684, 04953170383519

Source

Official record: FDA (Device enforcement) ↗

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