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Recall Observatory FDA recall evidence

Device product

Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Z-0780-2021

November 13, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 86826
Status
Terminated
Classification
Class II
Quantity
90
Official record key
device-enforcement:Z-0780-2021

Official wording

Reason: The cylindrical sponge component is not x-ray detectable.

Code information: Lot 20GBF988 (Expiration 06/30/2024); 20HBM404 (Expiration 06/30/2024); 20JBG876 (Expiration 09/30/2024)

Distribution pattern: Foreign distribution only - Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The cylindrical sponge component is not x-ray detectable.