Z-1232-06

Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855

Name: Z-1232-06 Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2006-06-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2006-06-19 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855 on 2006-06-19. The reason FDA records is "Sterility seal of the package tray may have gaps/voids compromising the sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1232-06
Status: Terminated
Initiated: 2006-06-19
Posted: 2006-07-13
Terminated: 2008-01-10
Recalling firm: Smith & Nephew, Inc.
Product: Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
Root cause tag: packaging
FDA 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 in commerce: 1026 boxes/Expanded 891 units
Distribution: Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul
Product codes and lots: Lot Numbers: Equal to or lower 50169658 (or within lot S595485S) Expanded Recall: Lot Numbers: 50169659, 50172149, 50172152, 50173174, 50174697, 50175101

Product code GEI

K031675Class IISmith & Nephew Dyonics Electroblade ResectorSmith & Nephew, Inc. / cleared 2003-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)