Class 2 Device Recall Instrument Tray, Basic T2 Femur Long

• Date Initiated by Firm: January 21, 2019
• Create Date: March 06, 2019
• Recall Status: Terminated on April 02, 2020
• Recall Number: Z-0980-2019
• Recall Event ID: 82140
• Product Classification: General surgery tray - Product Code LRO
• Product: Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
• Code Information: Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)
• Recalling Firm/ Manufacturer: Stryker GmbH; Bohnackerweg 1; Selzach Switzerland
• For Additional Information Contact: Elizabeth Beato; 201-831-5838
• Manufacturer Reason for Recall: The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
• FDA Determined Cause: Employee error
• Action: Zimmer Biomet issued Urgent Field Safety Notice PFA 1982723 customer letter dated: January 21, 2019. Letter identifies affected product, problem and action to be taken: Inform individuals within your organization who need to be aware of this action. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required, even you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the devices.
• Quantity in Commerce: 17 units
• Distribution: In the countries of Canada and Korea
• 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.