Recall Z-0320-2021 ยท OLO Orthopedic Stereotaxic Instrument
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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
| Date | Sep 11, 2020 |
| Status | Terminated |
| Reason | The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. |
| Root cause | Device Design |
| Action | On September 11, 2020, Pioneer Surgical sent out an advisory notice to their distributor (Surgalign) as a voluntary correction with no removal of devices from the field. However, after the advisory notice was distributed, a different issue related to the Streamline MIS Navigation taps becoming bound within Medtronic's Stealth Navigation System NavLock Tracker was reported. As a result, a second notification was sent out on September 24, 2020, changing the action to a voluntary recall. All instruments from the Streamline MIS Navigation System (as well as the Streamline TL Navigation System) wer |
| Quantity | 143 units |
| Distribution | Product distributed to Surgalign, a distributor located in Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200095 | Streamline Navigated Instruments Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc., Jun 26, 2020 |