Z-0705-04

Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398

Name: Z-0705-04 Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398
Creator: Smith And Nephew, Inc. Endoscopy Division
Published: 2004-02-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2004-02-19 / Terminated / root cause: sterility

FDA source

Smith And Nephew, Inc. Endoscopy Division began a recall of Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398 on 2004-02-19. The reason FDA records is "Endocouplers assembled with screws that cannot be effectively sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0705-04
Status: Terminated
Initiated: 2004-02-19
Posted: 2004-07-20
Terminated: 2006-06-28
Recalling firm: Smith & Nephew, Inc.
Product: Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398
Product code: FXM Camera, Still, Endoscopic
Reason for recall: Endocouplers assembled with screws that cannot be effectively sterilized
Root cause tag: sterility
FDA 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 in commerce: 2 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
Product codes and lots: Serial #s: 50001621-2 50001621-1

Product code FXM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)