Mammotome EX Holster
FDA device recall Z-0440-05 · posted 2005-01-27 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- 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.
- Action taken
- The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 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 foreig
- Date initiated
- 2004-12-10
- Date posted
- 2005-01-27
- Date terminated
- 2008-10-29
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAMMOTOME EX HAND HELD SYSTEM (K033700) | Ethicon Endo-Surgery, Inc. | 2004-02-20 |