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Recall Observatory FDA recall evidence

Device product

Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.

Z-1910-2016

May 04, 2016

Class II

Product summary

Firm
Stryker Corporation
Event
Event 74070
Status
Terminated
Classification
Class II
Quantity
21 units
Official record key
device-enforcement:Z-1910-2016

Official wording

Reason: Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction

Code information: Lot Numbers Affected: 13604

Distribution pattern: GA, UT, MD, NJ, MT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction