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U.S. Department of Health and Human Services

Class 2 Device Recall ATN System

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  Class 2 Device Recall ATN System see related information
Date Initiated by Firm December 20, 2017
Date Posted March 14, 2018
Recall Status1 Terminated 3 on April 22, 2020
Recall Number Z-1227-2018
Recall Event ID 79408
510(K)Number K010780  K013563  K042325  K111663  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product ACE Trochanteric Nail System
STER TROC NAIL 125 DEG X 9MM
STER TROC NAIL 130 DEG X 9MM
STER TROC NAIL 135 DEG X 9MM

The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
Code Information 903209125 903209130 903209135  
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall		 Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
FDA Determined
Cause 2		 Device Design
Action On December 22, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers with a complete list of products subject to recall and requesting that the customer review the notification and notify all affected personnel of the recall. If there is affected product at the facility it is requested that these units be quarantined and returned to a sales representative for return to the firm. Questions or concerns can be directed to 574-371-3071.
Quantity in Commerce 3454
Distribution USA (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 = HSB and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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