Z-0201-2020 Class I Terminated
FDA device recall Z-0201-2020 was initiated by Ethicon Endo-Surgery Inc on October 3, 2019 and is designated Class I. Reason for recall: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple… The recall status is terminated (terminated June 3, 2021). Affected quantity: 255 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- October 3, 2019
- Termination Date
- June 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 255 units
Product Description
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Reason for Recall
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Distribution Pattern
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
Code Information
Lot: T93Z9Y, T9411A