Z-2077-2009

DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number...

Name: Z-2077-2009 DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2009-05-27
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-05-27 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005 on 2009-05-27. The reason FDA records is "The sterility of the device cannot be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2077-2009
Status: Terminated
Initiated: 2009-05-27
Posted: 2009-09-21
Terminated: 2012-05-08
Recalling firm: Smith & Nephew, Inc.
Product: DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005
Product code: HRX Arthroscope
Reason for recall: The sterility of the device cannot be assured
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.
Quantity in commerce: 67,697 units
Distribution: Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.
Product codes and lots: Lot Numbers: 0149J, 0149H, 0149K, 0769P, 0799N, 0899K, 0919K, 09609W, 1688L, 1788H, 1798F, 1918F, 1928H, 1928HR, 1998X, 2218H, 2258F, 2278F, 2328H, 2388J, 2398F, 2418T, 2478K, 2758U, 2758Y, 2758Y, 2778F, 2778FR, 2898F, 2908X, 2908Y, 3048N, 3098F, 3258U, 3258V, 3468U, and 3468V.

Product code HRX

K051326Class IISmith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. / cleared 2005-06-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)