Class 2 Device Recall Endotrac ECTR Hook/Triangle Blade Kit

• Date Initiated by Firm: April 30, 2019
• Create Date: June 20, 2019
• Recall Status: Terminated on September 18, 2020
• Recall Number: Z-1848-2019
• Recall Event ID: 82894
• 510(K)Number: K922391
• Product Classification: Arthroscope - Product Code HRX
• Product: Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
• Code Information: Lot # 01410
• FEI Number: 3002807830
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Elizabeth Beato; 201-831-5838
• Manufacturer Reason for Recall: The seal integrity of the sterile bag containing the kits may be compromised.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.
• Quantity in Commerce: 447
• Distribution: The products were distributed US nationwide.
• 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 = HRX