Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.

Company: Stryker Sustainability Solutions
Recall Initiated: May 8, 2018
Terminated: July 29, 2019
Recall Number: Z-2484-2018
Quantity: 180 units
Firm Location: Tempe, AZ

Reason for Recall

Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.

Distribution

US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN

Lot / Code Info

Lot number 7656512

Root Cause

Device Design

Action Taken

Firm notified sales reps via email on 5/8/18 and instructed to have the customers complete response forms.

Reason for Recall

Distribution

Lot / Code Info

Root Cause

Action Taken

More recalls by Stryker Sustainability Solutions