Recall Z-2078-2009 ยท HRX Arthroscope
Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006
| Date | Sep 21, 2009 (initiated May 27, 2009) |
| Status | Terminated |
| Reason | The sterility of the device cannot be assured |
| 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 | 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, Braz |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051326 | SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM Smith & Nephew, Inc., Jun 15, 2005 |