Z-0589-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units (7 US, 63 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.