ClearanceBrief
Recall Z-1910-2016 ยท NBH Accessories, Arthroscopic

Stryker Corporation

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.

DateJun 3, 2016 (initiated May 4, 2016)
StatusTerminated
ReasonComplaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction
Root causeDevice Design
ActionA recall letter was not sent as all affected devices have been returned. A ship hold was placed on the device on October 16, 2015.
Quantity21 units
DistributionGA, UT, MD, NJ, MT
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.