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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Natural Nail System

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  Class 2 Device Recall Zimmer Natural Nail System see related information
Date Initiated by Firm June 17, 2015
Date Posted July 13, 2015
Recall Status1 Terminated 3 on March 15, 2016
Recall Number Z-2060-2015
Recall Event ID 71530
510(K)Number K083497  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Code Information Part 47-2492-320-10; lot 62763724
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
FDA Determined
Cause 2		 Process control
Action On 6/17/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.
Quantity in Commerce 8
Distribution Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
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 = ZIMMER, INC.
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