Events

Recall of Device Recall Smith & Nephew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith And Nephew, Inc. Endoscopy Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28423
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-04
  • Event Initiated Date
    2004-02-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31812
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Camera, Still, Endoscopic - Product Code FXM
  • Reason
    Endocouplers assembled with screws that cannot be effectively sterilized.
  • 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.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Part No: 7204823 Serial #s: SR 8433  SR 8472  SR 8504  SR 8562  SR 8391  SR 8506  SR 8538  SR 8555  SR 8392  SR 8395  SR 8489  SR 8494  SR 8554  SR 8471  SR 8485  SR 8477  SR 8568  SR 8513  SR 8514  SR 8394  SR 8520  SR 8493  SR 8567  SR 8569  SR 8396  SR 8533  SR 8561  SR 8534  7204823S SR 8623 SR 8422 SR 8563 SR 8590 SR 8577 SR 8591 SR 8628 SR 8495 SR 8576 SR 8627 SR 8426 SR 8490 SR 8499 SR 8587 SR 8573 SR 8428 SR 8574 SR 8578 SR 8580 SR 8589 SR 8565 SR 8566 SR 8498 SR 8564 SR 8620
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    Endocoupler, C-Mount 30 mm Focal Length || Catalog Number: 7204823, 7204823S
  • Manufacturer
    Smith And Nephew, Inc. Endoscopy Division

Manufacturer

Smith And Nephew, Inc. Endoscopy Division
  • Manufacturer Address
    Smith And Nephew, Inc. Endoscopy Division, 150 Minuteman Rd, Andover MA 01810-1031
  • Source
    USFDA