medical Class II Updated 2020-11-11

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Navigated Instruments, Catalog numbers 26-DRI

Recalled Product

Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.


Hazard / Issue

System does not include a drill guide.

Issued by

FDA

Distribution: Distributed to one distributor in Michigan.
Lot/Code Info: Lots 370855 373847 373848 373849 377629 373850 373846
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