Reported Jun 25, 2014 · Terminated
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Synthes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
- Lot codes and dates
- All
- lot numbers of multiple part numbers
204 of 204 codes
293.35293.36293.40293.41293.42293.44293.45293.46293.47293.48293.48L293.48X293.49293.50293.51293.52293.53293.54293.58293.59293.62293.63293.67293.68293.69293.72293.73293.74293.78293.83293.88293.93294.30294.30SHA294.43294.43SHA294.44294.44SHA294.45294.455294.45SHA294.46294.46SHA294.48294.52294.52SHA294.53SHA294.54294.54SHA294.55294.55SHA294.56294.56SHA294.57294.57SHA294.65294.66294.67294.67SHA294.68
- Amount recalled
- 5,114,052
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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