FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983
- Recall number
- Z-1233-06
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983
- Status
- Terminated
- Initiated
- 2006-06-19
- Posted
- 2006-07-13
- Terminated
- 2008-01-10
- 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
- Lot, serial or model codes
- Lot Numbers: Equal to or lower 50170383 Expanded Recall: Lot Numbers: 50172146, 50172147, 50172148, 50172150, 50172151, 50173171, 50174789, 50175087, 50175088, 50175089, 50175090
- 510(k) numbers
- ["K031675"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28