Recalls / —

—#46836

Product

Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983

FDA product code

GEI — Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K031675

Affected lot / code info

Lot Numbers: Equal to or lower 50170383 Expanded Recall: Lot Numbers: 50172146, 50172147, 50172148, 50172150, 50172151, 50173171, 50174789, 50175087, 50175088, 50175089, 50175090

Why it was recalled

Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Smith & Nephew, Inc. Endoscopy Division

Address

150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul

Timeline

Recall initiated

2006-06-19

Posted by FDA

2006-07-13

Terminated

2008-01-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #46836. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.