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U.S. Department of Health and Human Services

Class 1 Device Recall DePuy Synthes Craniomaxillofacial Distraction System

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  Class 1 Device Recall DePuy Synthes Craniomaxillofacial Distraction System see related information
Date Initiated by Firm April 16, 2014
Date Posting Updated August 20, 2014
Recall Status1 Terminated 3 on September 09, 2015
Recall Number Z-2148-2014
Recall Event ID 68071
510(K)Number K060138  
Product Classification External mandibular fixator and/or distractor - Product Code MQN
Product DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
Code Information Part nos. 04.315.003, 04.315.004, 04.315.005, 04.315.006, 04.315.023, 04.315.024, 04.315.025, 04.315.026, 04.315.027, 04.315.028, 04.315.053, 04.315.054, 04.315.055, 04.315.056, 04.315.063, 04.315.064, 04.315.065, 04.315.066, 04.315.067, 04.315.068, with lot nos.: 6245205, 7129328, IS10400, 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148

6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818

6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824, 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179, 7458272, 7458273, 7458274, IS10394, 6450702, 6454139, 6553925, 6625840, 6883404, 6921586, 7031344, 7185897, 7389329, 7408181, 7422706, 7422707, 7422708, 7458299, 7515832, IS10385, 6393118, 6393119, 6410545, 6454140, 6512859, 6625841, 6651391, 6984925, 7185895, 7408182, 7422703, 7422704, 7422705, 7515829, 7515830, 6393120, 7408180, 7515833

7122918, 7389333, 7422700, 7545381, IS10388, 6252759, 7129331, 7155891, 7418771, 7448753

6245463, 6438376, 6981568, 6983876,7063885, 7129332,7309797, 7418772, 7418848, 7448754, 6251769, 7081953, 7310030, 7365542, 7418849, 7448752, 7448758, 7556149, 6245458, 6342007, 7129333, 7556150, IS10399, 6245462, 6342003, 6824546, 6824551, 6883290, 6883301, 7082907, 7266972, 7476792, 7476810, 7657623, 6280719, 6342004, 6394297, 6651390, 6737168, 6767617, 6824547, 6824550, 6883304, 6883305, 6961025, 6984927, 7041138, 7056051, 7111867, 7185893, 7266967, 7351857, 7351858, 7351859, 7351861, 7422701, 7545379, 7657820, IS10395, 6651389, 6702172, 6883306, 6883307, 6942444, 6984926, 7111868, 7185892, 7306562, 7306563, 7306564, 7499078, 7515834, 7657629, IS10389, 6651388, 6741835, 6824553, 6883309, 6913921, 6942445, 6961024, 7082908, 7111869, 7122924, 7185888, 7515835, 7657633, 6921585, 6942446, 7185887, 7306565, 7306566, 7408183, 7476791, 7567066, 7579433, 7657635, IS10390, IS10391,, 6275129, 7082905, 7185890, 7266969, 7422697, 7609200, IS10386, IS10387



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
DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.
FDA Determined
Cause 2
Device Design
Action The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product. For questions call 610-719-5450 or contact your DePuy Synthes Sales consultant.
Quantity in Commerce 1499
Distribution US Nationwide 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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