Recall Z-2646-2011 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated
| Date | Jun 24, 2011 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU) |
| Root cause | Labeling mix-ups |
| Action | Smith & Nephew sent an "URGENT FIELD CORRECTION NOTIFICATION" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smi |
| Quantity | 11 units |
| Distribution | Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102544 | SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY Smith & Nephew Inc., Endoscopy Div., Jan 5, 2011 |