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Terminated

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.

FDA Recall Z-1927-2011 · Posted 2011-04-08

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2011-03-07
Date Terminated2011-10-04
Product Quantity2618 devices

Reason for Recall

Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.

Firm 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].

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944210ARTHROSCOPE ACCESSORIESStryker Endoscopy · 1995-02-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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