Z-0440-05

Mammotome EX Holster

Name: Z-0440-05 Mammotome EX Holster
Creator: Ethicon Endo-Surgery
Published: 2004-12-10
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2004-12-10 / Terminated

FDA source

Ethicon Endo-Surgery began a recall of Mammotome EX Holster on 2004-12-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0440-05
Status: Terminated
Initiated: 2004-12-10
Posted: 2005-01-27
Terminated: 2008-10-29
Recalling firm: Ethicon Endo-Surgery Inc
Product: Mammotome EX Holster
Product code: KNW Instrument, Biopsy
Reason for recall: 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.
FDA root cause: Other
Action: The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.
Quantity in commerce: 120 devices
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 codes and lots: 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 code KNW

K033700Class IIMammotome Ex Hand Held SystemEthicon Endo-Surgery, Inc. / cleared 2004-02-20

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)