Recall Z-0278-2016— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0278-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-23

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2015-09-23, terminated 2016-11-01. It names one FDA 510(k) clearance: K132612. Product: 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.. Reason: Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Terminated: 2016-11-01
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K132612 — HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCEEthicon Endo-Surgery, LLC·cleared 2013-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.