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Catalog Number 031336510 |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Problem with Sterilization (1596)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Contacted denmat holdings regarding instruction for use for their cerisaw anterior finishing system.There were no instructions for use for cleaning or sterilization provided contacted customer service / regulatory.Was told to autoclave but cannot provide a temperature, exposure time or cycle type.Requested specific info and was told to sterilize at 400 to 425 degree f.Advised the company this was unacceptable and we will be reporting them to the fda for f/u.
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Search Alerts/Recalls
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