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Terminated

Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961

FDA Recall Z-1230-06 · Posted 2006-07-13

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-06-19
Date Terminated2008-01-10
Product Quantity445 boxes/Expanded 348 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.

K031675SMITH & NEPHEW DYONICS ELECTROBLADE RESECTORSmith & Nephew, Inc. · 2003-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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