Events

Recall of Device Recall Mammotome EX Holster (Product Code HHEX)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery.

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
    30718
  • Event Risk Class
    Class 3
  • Event Number
    Z-0440-05
  • Event Initiated Date
    2004-12-10
  • Event Date Posted
    2005-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36451
  • 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
    Instrument, Biopsy - Product Code KNW
  • Reason
    A capacitor of the wrong value was used. the capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.
  • Action
    The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.

Device

Device Recall Mammotome EX Holster (Product Code HHEX)
  • Model / Serial
    HRDE39904, HRDE40502, HRDE40102, HRDE39920 HRDE40209, HRDE40204, HRDE39916, HRDE40220 HRDE39921, HRDE40114, HRDE40225, HRDE40508 HRDE40210, HRDE40222, HRDE39919, HRDE39906 HRDE40218, HRDE40724, HRDE40109, HRDE39903 HRDE40106, HRDE40118, HRDE40203, HRDE40113 HRDE40511, HRDE40206, HRDE39908, HRDE39910 HRDE40701, HRDE40513, HRDE40713, HRDE40720 HRDE40718, HRDE40710, HRDE40704, HRDE40716 HRDE40706, HRDE40520, HRDE40722, HRDE40708 HRDE40714 HRDE40522, HRDE40719, HRDE40705 HRDE40525, HRDE40527, HRDE40721, HRDE40703 HRDE40516, HRDE40725, HRDE40709, HRDE40702 HRDE40715, HRDE40518, HRDE40506, HRDE40519 HRDE40707, HRDE40712, HRDE40711, HRDE39922 HRDE40103, HRDE39901, HRDE40126, HRDE40120 HRDE39905, HRDE40723, HRDE40101, HRDE40205 HRDE40214, HRDE40526, HRDE40618, HRDE39902 HRDE40202, HRDE40122, HRDE40217, HRDE40221 HRDE40216, HRDE40624, HRDE39924, HRDE40717 HRDE40226, HRDE40503, HRDE40213, HRDE40107 HRDE40110, HRDE40524, HRDE40121, HRDE40514 HRDE39925, HRDE39909, HRDE39912, HRDE40505 HRDE40112, HRDE40212, HRDE40510, HRDE40208 HRDE40201, HRDE39907, HRDE39926, HRDE40124 HRDE40223, HRDE39923, HRDE40219, HRDE40111 HRDE40509, HRDE40515, HRDE40517, HRDE40108 HRDE39918, HRDE40521, HRDE40123, HRDE39914 HRDE39915, HRDE40501, HRDE40211 HRDE40224 HRDE40105, HRDE40207, HRDE39911, HRDE39911,  HRDE 39913
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to consignees located in MI, TN, IL, NC, GA, IL, CA, FL, IN, WI, TX, AR, KS, IA, OK, NY, PA, MS, KY, ME, MO, MA, VA, NJ, LA, MN, SD, UT, CO, AL, and NH. There are no foreign consignees.
  • Product Description
    Mammotome EX Holster
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery
  • Manufacturer Address
    Ethicon Endo-Surgery, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Source
    USFDA