Streamline OCT Navigated Instruments — Class II medical device recall Z-0322-2021
Ongoing recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), reported 2020-11-11, distributed in MI. System does not include a drill guide.
| Recall number | Z-0322-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI, United States |
| Recall initiated | 2020-09-24 |
| Classified | 2020-11-02 |
| Reported by FDA | 2020-11-11 |
| Distributed | MI |
| Quantity | 76 units |
| Lot numbers | 370855, 373846, 373847, 373848, 373849, 373850, 377629 |
| Model numbers | 26-DRILL-MDN, 26-FTAP-30-MDN, 26-FTAP-35-MDN, 26-FTAP-40-MDN, 26-FTAP-45-MDN, 26-S-FINDER-MDN |
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 for recall
System does not include a drill guide.
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-0322-2021. 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.