Recall Z-2048-2018— Ethicon Endo-Surgery Inc

Name: FDA recall Z-2048-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-03

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2018-05-03, terminated 2019-11-25. It names one FDA 510(k) clearance: K121550. Product: HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.. Reason: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-03
Terminated: 2019-11-25
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K121550 — HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGYEthicon Endo-Surgery, LLC·cleared 2012-08-22

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 Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Reason for recall

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

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