Z-0003-2021 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 Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - 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: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X