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U.S. Department of Health and Human Services

Class 2 Device Recall smith & nephew

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  Class 2 Device Recall smith & nephew see related information
Date Initiated by Firm July 30, 2013
Create Date February 18, 2016
Recall Status1 Terminated 3 on February 24, 2021
Recall Number Z-0818-2016
Recall Event ID 72911
Product Classification Accessories,arthroscopic - Product Code NBH
Product High Flow Irrigation Extender; Part Number 72201021.

Arthroscopic accessories are indicated for use in access of the joint capsule.
Code Information 50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc., Endoscopy Div.
130 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact
800-343-5717 Ext. 3
Manufacturer Reason
for Recall		 During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent - Product Recall 1st Notification - Urgent R-2013-13 letters, dated July 30, 2013 were sent overnight via Federal Express to customers. The letters identified the affected product, as well as the potential risk involved. Actions to be taken were provided for both hospital and sales representatives. Hospital representatives were asked to inspect their inventory, locate all devices from the list provided, and quarantine them immediately. The Inventory Return Certification Form should be completed and returned, regardless of whether any affected product is on hand or not. Contact the Smith & Nephew Returns Group at 800-343-5717 option 3) or send an e-mail to ProductRecovery@smith-nephew.com. They will provide instructions for returning affected product and receiving a replacement.
Quantity in Commerce 203 units
Distribution Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.
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.
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