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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68072

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 10, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.

Z-1833-2014
Recall number
Z-1833-2014
Initiated
April 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
Synthes, Inc.
Quantity
5,114,052

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 294.792 294.792SHA 294.793 294.793SHA 294.794 294.794SHA 294.795 294.795SHA 294.796 294.796SHA 294.798 294.798SHA 494.769 494.771 494.771SHA 494.772 494.772SHA 494.774 494.775 494.775SHA 494.776 494.776SHA 494.777 494.777SHA 494.778 494.778SHA 494.779 494.779SHA 494.782 494.782SHA 494.783 494.783SHA 494.784 494.784SHA 494.786 494.786SHA 494.788 494.788SHA 494.792 494.793 494.794 494.795 494.796 494.798 294.950 293.790 293.840 293.890 293.940 390.002 390.003 390.004 390.005 390.006 390.007 390.008 390.009 390.010 390.011 390.012 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 494.785 494.785SHA 390.041 390.042 395.60 395.61 395.62 395.63 395.64 395.65 395.66 395.67 395.680 395.681 395.682 395.685 395.686 395.687 395.688 03.301.010s 03.301.011s 03.301.012s 03.301.013s

Distribution pattern

Worldwide Distribution - USA (nationwide) and Canada.