FDA Device recall Z-1833-2014
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components by Synthes, citing labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1833-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-10 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Reason
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Identifiers
| code_info | All lot numbers of multiple part numbers:293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48…All lot numbers of multiple part numbers:293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48 293.48L 293.48X 293.49 293.50 293.51 293.52 293.53 293.54 293.58 293.59 293.62 293.63 293.67 293.68 293.69 293.72 293.73 293.74 293.78 293.83 293.88 293.93 294.30 294.30SHA 294.43 294.43SHA 294.44 294.44SHA 294.45 294.455 294.45SHA 294.46 294.46SHA 294.48 294.52 294.52SHA 294.53SHA 294.54 294.54SHA 294.55 294.55SHA 294.56 294.56SHA 294.57 294.57SHA 294.65 294.66 294.67 294.67SHA 294.68 294.68SHA 294.71 294.72 294.73 294.73SHA 294.74 294.74SHA 294.75 294.75SHA 294.76 294.767 294.768 294.769 294.769SHA 294.76SHA 294.771 294.771SHA 294.772 294.772SHA 294.773 294.774 294.775 294.775SHA 294.776 294.776SHA 294.777 294.777SHA 294.778 294.778SHA 294.779 294.779SHA 294.782 294.782SHA 294.783 294.783SHA 294.784 294.784SHA 294.785 294.785SHA 294.786 294.786SHA 294.788 294.788SHA 294.792 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1833-2014%22
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