Streamline TL Navigation System — Class II medical device recall Z-0300-2021
Terminated recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), reported 2020-11-04, distributed nationwide. The Streamline Navigation System taps have experienced binding with other devices.
| Recall number | Z-0300-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI, United States |
| Recall initiated | 2020-09-24 |
| Classified | 2020-10-27 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2024-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 420 |
| Lot numbers | 366798, 366799, 367040, 369372, 370212, 370853, 371729, 371730, 371731, 372813, 372815, 372816, 372817, 372923, 372924, 372925, 372926, 372927, 373437, 373845, 373852, 377616, 377619, 377620, 377621, 377622, 377623, 377624 |
| Model numbers | 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-MODHANDLE-MDN, 02-RS-INS-C-MDN, 02-RS-INSERTER-MDN, 02-S-FINDER-L-MDN, 02-S-FINDER-T-MDN, 02-SCREWINS-C-MDN, 02-SCREWINS-CL-MDN, 02-SFINDER-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 and 1 more |
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 for recall
The Streamline Navigation System taps have experienced binding with other devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0300-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.