FDA Medical Device Recalls (openFDA)
Smith And Nephew, Inc. Endoscopy Division: Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461
- Recall number
- Z-0708-04
- Recalling firm
- Smith And Nephew, Inc. Endoscopy Division
- Product
- Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461
- Status
- Terminated
- Initiated
- 2004-02-19
- Posted
- 2004-07-20
- Terminated
- 2006-06-28
- Reason
- Endocouplers assembled with screws that cannot be effectively sterilized
- Root cause
- Other
- Action
- Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.
- Quantity
- 102 units
- Distribution
- AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal, South Africa, Spain, Turkey, UK
- Lot, serial or model codes
- Part No: 7205461 Serial #s: UE 1130 UE 1234 UE 1142 UE 1127 UE 1143 UE 1212 UE 1216 UE 1222 UE 1226 UE 1217 UE 1145 UE 1227
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FXM
- 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