FDA Device recall Z-0322-2021
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-M…
- FDA Device
- Class II
- ongoing
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of 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-M… by Rti Surgical Dba Pioneer Surgical Technology, citing system does not include a drill guide.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0322-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-24 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Rti Surgical Dba Pioneer Surgical Technology |
| Distribution | MI |
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.
Reason
System does not include a drill guide.
Identifiers
| code_info | Lots 370855 373847 373848 373849 377629 373850 373846 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2021%22
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