Z-1830-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- May 17, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,113,280
Product Description
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Reason for Recall
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Distribution Pattern
Nationwide domestic distribution, worldwide foreign distribution.
Code Information
N8L0311KY N8M0063KY