Z-2355-2021 Class II Ongoing
FDA device recall Z-2355-2021 was initiated by Ethicon Endo-Surgery Inc on July 20, 2021 and is designated Class II. Reason for recall: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns The recall status is ongoing. Affected quantity: 7870 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- July 20, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7870 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.