Recall Z-0440-05 ยท KNW Instrument, Biopsy
Ethicon Endo-Surgery
Mammotome EX Holster
| Date | Jan 27, 2005 (initiated Dec 10, 2004) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033700 | MAMMOTOME EX HAND HELD SYSTEM Ethicon Endo-Surgery, Inc., Feb 20, 2004 |