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Recall Observatory FDA recall evidence

Device product

D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.

Z-1277-2024

October 06, 2023

Class II

Product summary

Firm
Peter Lazic Gmbh
Event
Event 93938
Status
Ongoing
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-1277-2024

Official wording

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 information: Model number: 35.410; UDI/DI: 04250603739593; All Lot numbers.

Distribution pattern: US Nationwide distribution in the state of ME.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.