Recall Z-0322-2021 ยท OLO Orthopedic Stereotaxic Instrument
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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.
| Date | Nov 2, 2020 (initiated Sep 24, 2020) |
| Status | Open, Classified |
| Reason | System does not include a drill guide. |
| Root cause | Device Design |
| Action | On September 24, 2020, the firm sent an Urgent Medical Devices Recall letter to customers to inform them of the product issue. Customers were instructed to remove affected product from all user sites and inventory locations. Customers are to return these instrument systems to RTI Surgical using RGA number 63000897 along with a completed copy of the Acknowledgement and Receipt Form. If the product has been further distributed, please immediately notify your customers by providing them a copy of the recall letter and the response form for completion. |
| Quantity | 76 units |
| Distribution | Distributed to one distributor 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 |