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U.S. Department of Health and Human Services

Class 2 Device Recall Truliant Splined Stem Extension

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  Class 2 Device Recall Truliant Splined Stem Extension see related information
Date Initiated by Firm January 27, 2020
Create Date February 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-1364-2020
Recall Event ID 84961
510(K)Number K150890  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
Code Information Catalog no: 02-012-64-1812  Serial number: 6366405, 6367075, 6367076   
Recalling Firm/
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Jean-Philippe Gobeil-Jobidon
Manufacturer Reason
for Recall
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
FDA Determined
Cause 2
Labeling mix-ups
Action Exactech distributed the recall notice to the consignees in possession of affected inventory by electronic mail on 7 January 2020. In order to comply with the notice, consignees have been instructed to: "Immediately cease distribution or use of this product. "Extend the information to their accounts that may have this product in their possession. "Identify and quarantine any of the subject devices in their inventory "Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the states of AZ, CO and FL.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.