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U.S. Department of Health and Human Services

Class 2 Device Recall Instrument Tray, Basic T2 Femur Long

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  Class 2 Device Recall Instrument Tray, Basic T2 Femur Long see related information
Date Initiated by Firm January 21, 2019
Create Date March 06, 2019
Recall Status1 Terminated 3 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/
Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Elizabeth Beato
Manufacturer Reason
for Recall
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
FDA Determined
Cause 2
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.