Z-0652-2009

Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the...

Name: Z-0652-2009 Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the...
Creator: Stryker Endoscopy
Published: 2008-10-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-10-01 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump on 2008-10-01. The reason FDA records is "Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0652-2009
Status: Terminated
Initiated: 2008-10-01
Posted: 2009-01-21
Terminated: 2010-12-16
Recalling firm: Stryker Corp.
Product: Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
Product code: HRX Arthroscope
Reason for recall: Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Endoscopy initiated the recall 10/01/2008. Information gathered and recall packets sent via FedEx to all affected accounts. Packets included advisory notices and acknowledgement card, as well as shipping labels to return product. Each account was instructed to locate and quarantine product for return to Stryker endoscopy. Sales representatives received a voicemail/email notification that included a list of all affected accounts.
Quantity in commerce: 1440 devices
Distribution: Nationwide.
Product codes and lots: Lot number: 08E0451

Product code HRX

K944210Class IIArthroscope AccessoriesStryker Endoscopy / cleared 1995-02-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)