Z-1277-2024 Class II Ongoing
FDA device recall Z-1277-2024 was initiated by Peter Lazic Gmbh on October 6, 2023 and is designated Class II. Reason for recall: Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip. The recall status is ongoing. Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2024
- Initiation Date
- October 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
Reason for Recall
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
Distribution Pattern
US Nationwide distribution in the state of ME.
Code Information
Model number: 35.410; UDI/DI: 04250603739593; All Lot numbers.