Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large)
Medical device recall Z-2451-2015. Published in FDA’s Enforcement Report on Sep 2, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 2, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 5306080 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
5306080, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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…
FDA’s list runs to 3,751 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-including US (nationwide) and Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 29, 2015.
- FDA classified it on Aug 24, 2015.
- FDA’s Enforcement Report published it on Sep 2, 2015.
- FDA terminated it on Sep 27, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synthes (USA) Products LLC, of West Chester, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,751 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.