Class 2 Device Recall Reprocessed HARMONIC Ace 7, 5mm Diameter Shears with Advanced Hemostasis (HARH)

• Date Initiated by Firm: May 08, 2018
• Create Date: July 18, 2018
• Recall Status: Terminated on July 29, 2019
• Recall Number: Z-2484-2018
• Recall Event ID: 80329
• 510(K)Number: K161693
• Product Classification: Scalpel, ultrasonic, reprocessed - Product Code NLQ
• Product: 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.
• Code Information: Lot number 7656512
• FEI Number: 3009350690
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Firm notified sales reps via email on 5/8/18 and instructed to have the customers complete response forms.
• Quantity in Commerce: 180 units
• Distribution: US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NLQ