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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Craniomaxillofacial (CMF) Distraction System

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  Class 2 Device Recall Synthes Craniomaxillofacial (CMF) Distraction System see related information
Date Initiated by Firm June 12, 2013
Date Posted July 12, 2013
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-1726-2013
Recall Event ID 65670
510(K)Number K060138  
Product Classification External mandibular fixator and/or distractor - Product Code MQN
Product Synthes CMF Distraction System

The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Code Information Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Synthes Recall Information Center
610-719-5450
Manufacturer Reason
for Recall		 The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action SYNTHES sent an Urgent Notice: Medical Device Recall letter dated June 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to examine their inventory for affected product, remove it from use, and return it to Synthes. If they have affected product they were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter and indicate the number of devices found and note the Return Authorization Number and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers did not have the affected product they were asked to complete the Verification Section and faxt to 610-251-9005. Customers with questions were instructed to call 610-719-5450 or e-mail FieldAction@synthes.com. For questions regarding this recall call 610-719-5450.
Quantity in Commerce 10
Distribution Nationwide Distribution including PA, CT, DE, and NY.
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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