Z-0203-2020 Class I Terminated
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
- 2112 units
Product Description
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
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: T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R