Z-1825-2019 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 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
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
lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX