Z-1910-2016Class II

Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the...

Name: Z-1910-2016 Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the...
Creator: Stryker Corporation
Published: 2016-05-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-05-04 / Terminated / root cause: design

FDA source

Stryker Corporation began a recall of Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm... on 2016-05-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1910-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-06-03
Terminated: 2016-06-03
Recalling firm: Stryker Corp.
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.
Product code: NBH Accessories, Arthroscopic
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
Root cause tag: design
FDA root cause: 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
Product codes and lots: Lot Numbers Affected: 13604

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1910-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1910-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)