Recalls / —
—#146181
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.
- FDA product code
- NBH — Accessories, Arthroscopic
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Numbers Affected: 13604
Why it was recalled
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
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Stryker Corporation
- Address
- 5900 Optical Ct, San Jose, California 95138-1400
Distribution
- Distribution pattern
- GA, UT, MD, NJ, MT
Timeline
- Recall initiated
- 2016-05-04
- Posted by FDA
- 2016-06-03
- Terminated
- 2016-06-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.