Recall Z-0278-2016 ยท LFL Instrument, Ultrasonic Surgical
Ethicon Endo-Surgery Inc
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
| Date | Nov 16, 2015 (initiated Sep 23, 2015) |
| Status | Terminated |
| Reason | Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. |
| Root cause | Device Design |
| Action | On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers. |
| Quantity | 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, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE Ethicon Endo-Surgery, LLC, Oct 17, 2013 |