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Recall Observatory FDA recall evidence

Device product

Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Z-2275-2020

August 21, 2018

Class II

Product summary

Firm
Genicon, Inc.
Event
Event 85407
Status
Ongoing
Classification
Class II
Quantity
102 boxes (5 units per box)
Official record key
device-enforcement:Z-2275-2020

Official wording

Reason: There is potential for the plastic optical tip to become detached from the metal shaft.

Code information: Lots I7968-A, I8182-A

Distribution pattern: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is potential for the plastic optical tip to become detached from the metal shaft.