Recall Z-2145-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures
| Date | Aug 3, 2012 (initiated Jul 14, 2012) |
| Status | Terminated |
| Reason | Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated. |
| Root cause | Error in labeling |
| Action | Smith & Nephew sent an Urgent - Product Recall 1st Notification Letter dated July 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to examine inventory, quarantine immediately, complete the form attached indicating the lot numbers and quantities. The letter also instructed customers to contact Smith & Nephew Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. They will provide customers with instruction |
| Quantity | 108 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012314 | DYONICS ELECTROBLADE RESECTOR Smith & Nephew, Inc., Feb 1, 2002 |