Recall Z-1910-2016
Stryker Corporation · initiated May 4, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Numbers Affected: 13604
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1910-2016
- Initiated
- May 4, 2016
- Posted by FDA
- June 3, 2016
- Terminated
- June 3, 2016
- Product code
- NBH – Accessories, Arthroscopic
- Quantity
- 21 units
- Distribution
- GA, UT, MD, NJ, MT
- Recalling firm
- Stryker Corporation, San Jose, CA