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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer M/DN Intramedullary Fixation System

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  Class 2 Device Recall Zimmer M/DN Intramedullary Fixation System see related information
Date Initiated by Firm May 04, 2016
Date Posted May 16, 2016
Recall Status1 Terminated 3 on July 05, 2017
Recall Number Z-1678-2016
Recall Event ID 73981
510(K)Number K142281  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Code Information LOTS: 63295051 63293672 
Recalling Firm/
Manufacturer
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
FDA Determined
Cause 2
Packaging change control
Action All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Quantity in Commerce 219
Distribution Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
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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