Skip to content
Recall Observatory FDA recall evidence

Device product

DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

Z-2148-2014

April 16, 2014

Class I

Product summary

Firm
Synthes, Inc.
Event
Event 68071
Status
Terminated
Classification
Class I
Quantity
1499
Official record key
device-enforcement:Z-2148-2014

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.