Recall Z-1910-2016— Stryker Corporation

Class II · Terminated

Class II FDA medical device recall by Stryker Corporation, initiated 2016-05-04, terminated 2016-06-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.

Recalling firm
Stryker Corporation
Classification
Class II
Status
Terminated
Initiated
2016-05-04
Terminated
2016-06-03
Firm location
San Jose, CA, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.