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Recall Xvoid Kyphoplastie Systems, Sintea Biotech

Product group Medical instruments for use in humans
Reference 01088/08

The manufacturer Sintea Biotech recalls Xvoid Kyphoplastie Systems (affected lot numbers are listed in the Advisory Notice). During the vertebroplasty procedure the tip of the device separated. The manufacturer attributed this to a recently implemented design change. The new design modification will come back to the previous design, already tested and validated.

Recall Xvoid Kyphoplastie Systems, Sintea Biotech , Download_VeroeffentlichtAm_EN PDF, 111KB, File does not meet accessibility standards

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