Class 2 Device Recall Thermal Ligating Shears

• Date Initiated by Firm: March 22, 2019
• Create Date: June 01, 2019
• Recall Status: Terminated on July 30, 2020
• Recall Number: Z-1698-2019
• Recall Event ID: 82708
• 510(K)Number: K062257
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: TLS2 Thermal Ligating Shears, Catalog Number 132-131D
• Code Information: UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076
• Recalling Firm/ Manufacturer: Microline Surgical, Inc.; 50 Dunham Rd; Suite 1500; Beverly MA 01915-1882
• For Additional Information Contact: Scott Marchand Davis; 978-922-9810
• Manufacturer Reason for Recall: The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.
• Quantity in Commerce: 115 units
• Distribution: The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
• 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 = GEI