Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983
FDA Recall Z-1233-06 · Posted 2006-07-13
Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-06-19
Date Terminated2008-01-10
Product Quantity1833 boxes/Expanded Recall 1851 units
Reason for Recall
Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.