FDA Enforcement
Class II
Ongoing
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Recall: Z-1279-2024
·
Reported March 20, 2024
Enforcement
- Recall Number
- Z-1279-2024
- Event ID
- 93938
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Peter Lazic Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2024
- Initiation Date
- October 6, 2023
- Classification Date
- March 11, 2024
- Address
- Immelmannweg 2, N/A, Tuttlingen, N/A, N/A, Germany
Description
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Reason
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
Code Info
Model number: 35.412; UDI/DI: 04250603739616; All Lot numbers.
Distribution
US Nationwide distribution in the state of ME.
Quantity
10 units