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U.S. Department of Health and Human Services

Class 2 Device Recall Inflow/Outflow Cannula

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  Class 2 Device Recall Inflow/Outflow Cannula see related information
Date Initiated by Firm March 07, 2011
Date Posted April 08, 2011
Recall Status1 Terminated 3 on October 04, 2011
Recall Number Z-1927-2011
Recall Event ID 58143
510(K)Number K944210  
Product Classification Arthroscope - Product Code HRX
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.
Code Information Part number 747-031-650
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
408-754-2664
Manufacturer Reason
for Recall		 Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.
FDA Determined
Cause 2		 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 cannula@stryker.com. 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 cannula@stryker.com.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = Stryker Endoscopy
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