Z-1927-2011

Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The...

Name: Z-1927-2011 Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The...
Creator: Stryker Endoscopy
Published: 2011-03-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2011-03-07 / Terminated

FDA source

Stryker Endoscopy began a recall of Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The inflow/outflow cannula is intended as a general... on 2011-03-07. The reason FDA records is "Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1927-2011
Status: Terminated
Initiated: 2011-03-07
Posted: 2011-04-08
Terminated: 2011-10-04
Recalling firm: Stryker Corp.
Product: Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigation device for use in endoscopic surgeries. It will be used by orthopedic surgeons in arthroscopic knee and shoulder procedures as well as used in conjunction with the Stryker Flow Control Arthroscopy pump and with all 502-477-xxx scopes. The design included dual scope sheaths made of metal that offer two important features. First, it will separate the inflow irrigation to the operative site from the outflow irrigation out of the operative site. Second, the cannula will have a dual stopcock design that will separately control the inflow and outflow irrigation ports.
Product code: HRX Arthroscope
Reason for recall: Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.
FDA root cause: Other
Action: The firm, Stryker, issued an "URGENT: DEVICE CORRECTION" memo dated March 8, 2011 to all customers. The memo described the product, problem and actions to be taken. The customers were instructed to discard any old Instructions for Use (1000-400-816 rev. A or B) for their Inflow/Outflow Cannual; download the new IFU (1000-400-816 rev. C) from the URL link: http://stryker.com/InflowOutflowCannual; ensure they follow the new cleaning instructions provided in the IFU and complete and return the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in and email to [email protected]. Stryker stated in the memo that "It is important to send the self addressed confirmation forms back to Stryker RAQA". If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at [email protected].
Quantity in commerce: 2618 devices
Distribution: Worldwide distribution: USA including states of: AL, ALASKA, AK, AR, CA, CO, CT, DC, DE, FL, GA, ID IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: Australia, Canada, China, France, Germany, India, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Switzerland and United Kingdom.
Product codes and lots: Part number 747-031-650

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)