Recall Z-1233-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Smith & Nephew, Inc. Endoscopy Division
Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983
| Date | Jul 13, 2006 (initiated Jun 19, 2006) |
| Status | Terminated |
| Reason | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. |
| Root cause | Other |
| Action | Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers. |
| Quantity | 1833 boxes/Expanded Recall 1851 units |
| Distribution | Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031675 | SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR Smith & Nephew, Inc., Jun 20, 2003 |