Z-0001-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- August 12, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900,007 total
Product Description
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reason for Recall
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Distribution Pattern
Worldwide distribution - US Nationwide and Global Distribution.
Code Information
Lot Numbers: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X