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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 Posted August 20, 2014
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQN and Original Applicant = SYNTHES (USA)
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