RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP…
- Recall date
- September 24, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0322-2021
- FDA classification
- Class II
- Brand / firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Sold / distributed
- Distributed to one distributor in Michigan.
Why it was recalled
System does not include a drill guide.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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