Mammotome EX Holster
FDA Recall Z-0440-05 · Posted 2005-01-27
Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeKNW
Date Initiated2004-12-10
Date Terminated2008-10-29
Product Quantity120 devices
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.
Firm Action
The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.