Recall Z-0463-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.
| Date | Jan 11, 2012 (initiated Nov 7, 2011) |
| Status | Terminated |
| Reason | Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use. |
| Root cause | Process control |
| Action | Smith & Nephew Inc. Endoscopy Division notified facilities on 11/7/11 via an "Urgent - Product Recall 1st Notification - Urgent" letter and/or phone. The letter identified the affected product and the reason for the recall. It also discussed the potential risks, customer actions, and instructions for the return of the product. Customers were to check their inventory and locate any of the affected product. They were to also complete the requested contact information and return the notification letter. In addition, customers were to contact Smith & Nephew Endoscopy Division Returns Group at |
| Quantity | 1743 units |
| Distribution | Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Dubai, Finland, France, Germany, Norway, South Africa, Switzerland, United Kingdom, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012314 | DYONICS ELECTROBLADE RESECTOR Smith & Nephew, Inc., Feb 1, 2002 |