DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Synthes, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2148-2014
Related Recalls
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.