Recall Z-0300-2021 ยท OLO Orthopedic Stereotaxic Instrument
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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 0
| Date | Oct 27, 2020 (initiated Sep 24, 2020) |
| Status | Terminated |
| Reason | The Streamline Navigation System taps have experienced binding with other devices. |
| Root cause | Device Design |
| Action | On September 24, 2020, the firm distributed the Urgent Medical Devices Recall letter to customers. Customers were instructed to remove affected product from all user sites and inventory locations. These instrument systems are to be returned to RTI Surgical along with a completed copy of the response form. Accounts who have further distributed the affected products are also asked to immediately notify their customers by providing them a copy of the recall letter and the response form for completion when returning the affected devices to RTI Surgical. |
| Quantity | 420 |
| Distribution | US Nationwide distribution including in the state of 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 |