Z-0818-2016Class II

High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access...

Name: Z-0818-2016 High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access...
Creator: Smith & Nephew, Inc., Endoscopy Div.
Published: 2013-07-30
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-07-30 / Terminated

FDA source

Smith & Nephew, Inc., Endoscopy Div. began a recall of High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule on 2013-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0818-2016
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2016-02-18
Terminated: 2021-02-24
Recalling firm: Smith & Nephew, Inc.
Product: High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Product code: NBH Accessories, Arthroscopic
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 root cause: 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 [email protected]. 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0818-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0818-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-17

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)