FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)
- Recall number
- Z-0725-2007
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished)
- Status
- Terminated
- Initiated
- 2007-03-01
- Posted
- 2007-04-07
- Terminated
- 2008-07-14
- Reason
- Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
- Root cause
- Other
- Action
- Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
- Quantity
- 12, 292 units for all recalls Z-0724-0726-07
- Distribution
- World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBW
- 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