FDA Device recall Z-0300-2021
Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TA…
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TA… by Rti Surgical Dba Pioneer Surgical Technology, citing the Streamline Navigation System taps have experienced binding with other devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0300-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-24 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Rti Surgical Dba Pioneer Surgical Technology |
| Distribution | US |
Product
Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FINDER-L-MDN 02-SFINDER-MDN 02-S-FINDER-T-MDN 02-TAP-45-MDN 02-TAP-55-MDN 02-TAP-60-L-MDN 02-TAP-65-L-MDN 02-TAP-65-MDN 02-TAP-75-L-MDN 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Reason
The Streamline Navigation System taps have experienced binding with other devices.
Identifiers
| code_info | Lots 372816 377619 372817 372813 372927 373852 377616 377620 372926 372925 372923 372924 366798 367040 3…Lots 372816 377619 372817 372813 372927 373852 377616 377620 372926 372925 372923 372924 366798 367040 366799 370212 371729 377621 371730 373437 371731 372815 377622 373845 377623 369372 370853 377624 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0300-2021%22
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