The reported 4.5mm full radius platinum series blade, intended for use in treatment, will not be returned for evaluation.From the information provided, a small amount of ink seemed to rub off the device, but was quickly washed away.During the manufacture of all our blades no ink is used during the manufacturing process.An exact root cause cannot be determined with confidence without the return of the blade in question, however, factors that could have contributed to the reported event include: the presents of residual silicone lubricant from the manufacturing process, based on testing performed by smith+nephew the silicone lubricant does not pose any risk to patient safety.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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