Events

Recall of Device Recall Synthes Trauma ExFix System (Small, Medium, Distraction Osteogenesis (DO) and Large)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71876
  • Event Risk Class
    Class 2
  • Event Number
    Z-2451-2015
  • Event Initiated Date
    2015-07-29
  • Event Date Posted
    2015-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139263
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    Labeling changes were made related to mr conditions that align with standard definitions for mr safe, mr conditional, and mr unsafe. this recall identifies additional trauma external fixation system part numbers that should be considered mr conditional. one serious injury reported.
  • Action
    Urgent recall letters, dated July 31, 2015, were sent to end users and sales consultants to notifiy them about the issue, the associated risks, and to provide instructions for returning the affected devices and response form.

Device

Device Recall Synthes Trauma ExFix System (Small, Medium, Distraction Osteogenesis (DO) and Large)
  • Model / Serial
    All Lot Numbers of Part Numbers:  390.002 390.003 390.004 390.005 390.007 390.008 390.009 390.010 390.011 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 03.301.010S 03.301.011S 03.301.012S 03.301.013S 292.40 292.41 390.026 390.027 390.028 390.029 390.030 390.031 390.032 390.033 390.034 390.035 390.036 390.037 395.690 395.691 395.692 395.693 395.779 395.780 395.782 395.784 395.786 395.788 395.792 395.796 395.797 395.798 03.311.010 03.311.011 03.311.012 03.311.013 03.311.015 03.311.020 03.311.022 03.311.023 03.311.024 03.311.025 03.311.031 03.311.032 03.311.033 03.311.036 03.311.037 03.311.038 03.311.041 03.311.042 03.311.043 03.311.046 03.311.047 03.311.048 03.311.050 03.311.051 03.311.054 03.311.055 03.311.056 03.311.058 03.311.059 03.311.060 03.311.061 03.311.061.10 03.311.062 03.311.070 03.311.071 03.311.081 03.311.082 03.311.084 03.311.090 03.311.091 03.311.092 03.311.106 03.311.108 03.311.110 03.311.112 03.311.115 03.311.120 03.311.125 03.311.130 03.311.135 03.311.140 03.311.171 03.311.172 03.311.173 03.311.174 03.311.175 03.311.200 03.311.201 03.311.202 03.311.203 03.311.204 03.311.205 03.311.212 03.311.213 03.311.214 03.311.215 03.311.220 03.311.230 03.311.240 03.311.250 03.311.308 03.311.310 03.311.311 03.311.312 03.311.313 03.311.314 03.311.315 03.311.316 03.311.318 03.311.320 03.311.322 03.311.324 03.311.344 03.311.346 03.311.348 03.311.350 03.311.373 03.311.375 03.311.376 03.311.378 03.311.380 03.311.391 03.311.392 03.311.396 03.311.397 03.311.406 03.311.412 03.311.418 03.311.425 03.311.450 03.311.451 03.311.808 03.311.810 03.311.811 03.311.812 03.311.813 03.311.814 03.311.816 03.311.818 03.311.820 03.311.844 03.311.846 03.311.848 03.311.850 03.311.873 03.311.874 03.311.875 03.311.876 03.311.878 03.311.880 03.311.891 03.311.892 03.311.896 03.311.897 03.311.910 03.311.914 03.311.916 03.311.918 03.311.940 03.311.944 03.311.946 03.311.948 03.311.960 03.311.964 03.311.966 03.311.968 03.311.970 03.311.980 03.311.984 03.311.986 03.311.988 03.311.990 292.75 293.62 293.67 293.72 293.790 293.840 293.890 293.940 294.48 294.52 294.53 294.54 294.55 294.56 294.57 294.65 294.66 294.67 294.68 294.71 294.72 294.73 294.74 294.75 294.76 294.767 294.768 294.769 294.771 294.772 294.773 294.774 294.775 294.776 294.777 294.778 294.779 294.782 294.783 294.784 294.785 294.786 294.788 294.792 294.793 294.794 294.795 294.796 294.798 294.950 494.769 494.771 494.772 494.774 494.775 494.776 494.777 494.778 494.779 494.782 494.783 494.784 494.785 494.786 494.788 494.792 494.793 494.794 494.795 494.796 494.798 294.46SHA 294.52SHA 294.53SHA 294.54SHA 294.55SHA 294.56SHA 294.57SHA 294.67SHA 294.68SHA 294.73SHA 294.74SHA 294.75SHA 294.769SHA 294.76SHA 294.771SHA 294.772SHA 294.775SHA 294.776SHA 294.777SHA 294.778SHA 294.779SHA 294.782SHA 294.783SHA 294.784SHA 294.785SHA 294.786SHA 294.788SHA 294.792SHA 294.793SHA 294.794SHA 294.795SHA 294.796SHA 294.798SHA 494.771SHA 494.772SHA 494.775SHA 494.776SHA 494.777SHA 494.778SHA 494.779SHA 494.782SHA 494.783SHA 494.784SHA 494.785SHA 494.786SHA 494.788SHA 390.041 390.042 395.60 395.61 395.63 395.64 395.65 395.680 395.681 395.682 395.685 395.686 395.687 395.688 390.006 390.012 690.315 390.051 394.055 690.451 03.390.052S 03.390.053S 03.390.054S 03.390.055S 03.390.056S 03.390.057S SD311.202 SD311.203 SD311.204 SD311.205 SD357.100 293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48 293.49 293.50 293.51 293.52 293.53 293.54 293.58 293.59 293.63 293.68 293.69 293.73 293.74 293.78 293.83 293.88 293.93 294.30 294.43 294.44 294.45 294.455 294.46 293.48L 293.48X 294.30SHA 294.43SHA 294.44SHA 294.45SHA 395.62 395.66 395.67 690.978 03.304.220S 03.304.222S 03.304.320S 03.304.322S
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-including US (nationwide) and Canada.
  • Product Description
    Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA