High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
FDA Recall Z-0818-2016 · Posted None
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Recalling FirmSmith & Nephew, Inc., Endoscopy Div.
Recall StatusTerminated
Product CodeNBH
Date Initiated2013-07-30
Date Terminated2021-02-24
Product Quantity203 units
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.
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 [email protected]. They will provide instructions for returning affected product and receiving a replacement.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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