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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker FlowPort II Adapter

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  Class 2 Device Recall Stryker FlowPort II Adapter see related information
Date Initiated by Firm May 04, 2016
Date Posted June 03, 2016
Recall Status1 Terminated 3 on June 03, 2016
Recall Number Z-1910-2016
Recall Event ID 74070
Product Classification OR - Orthopedic - Product Code NBH
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.
Code Information Lot Numbers Affected: 13604
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
408-754-2664
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action A recall letter was not sent as all affected devices have been returned. A ship hold was placed on the device on October 16, 2015.
Quantity in Commerce 21 units
Distribution GA, UT, MD, NJ, MT
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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