FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: TriVex 200LV Resector Kit, 5.5 Part Number: 7209271
- Recall number
- Z-1227-06
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- TriVex 200LV Resector Kit, 5.5 Part Number: 7209271
- Status
- Terminated
- Initiated
- 2006-06-19
- Posted
- 2006-07-13
- Terminated
- 2008-01-10
- Reason
- The sterility seal of the package trays may have incomplete seals compromising the sterility of the device
- Root cause
- Other
- Action
- Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.
- Quantity
- 2856 units/Expanded 207 units
- Distribution
- Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
- Lot, serial or model codes
- Lot Numbers: All lot numbers lower than 50156900 Expanded recall: Lot Numbers: 50173181, 50175084
- 510(k) numbers
- ["K990723"]
- 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