Class II — RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
| Recalling firm | RTI Surgical, Inc. (dba RTI Biologics, Inc.) |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. |
| Product | Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN |
| Quantity | 143 units |
| Distribution | Product distributed to Surgalign, a distributor located in Michigan. |
| Initiated | 2020-09-11 |
| Classified | 2020-10-31 |
| Terminated | 2024-05-23 |
| Recall number | Z-0320-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) (Z-0320-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86591/
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