HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated
FDA device recall Z-0278-2016 · posted 2015-11-16 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery Inc
- Reason for recall
- Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
- Action taken
- On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 441,490 pieces
- Distribution
- Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN
- Date initiated
- 2015-09-23
- Date posted
- 2015-11-16
- Date terminated
- 2016-11-01
- Location
- Blue Ash, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612) | Ethicon Endo-Surgery, LLC | 2013-10-17 |