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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Mandible External Fixator

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  Class 2 Device Recall Synthes Mandible External Fixator see related information
Date Initiated by Firm October 17, 2014
Date Posted January 23, 2015
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-1009-2015
Recall Event ID 69533
510(K)Number K040169  K050378  
Product Classification External mandibular fixator and/or distractor - Product Code MQN
Product The Synthes Mandible External Fixator; all lots of part nos.:

04.305.003
04.305.004
04.305.005
04.305.010
04.305.011
04.305.012
03.305.006
04.305.100
04.305.101
04.305.102
04.305.103
04.305.128
04.305.130
04.305.134
04.305.138
04.305.140
04.305.142
03.305.105
03.305.500
03.305.500S

Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Code Information All lots of part nos.:  04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
FDA Determined
Cause 2		 Labeling design
Action Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.
Quantity in Commerce 43159
Distribution Worldwide Distribution.
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 = MQN and Original Applicant = SYNTHES (USA)
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