Z-0300-2021Class II

Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN...

Name: Z-0300-2021 Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN...
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2020-09-24
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2020-09-24 / Terminated / root cause: design

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of 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... on 2020-09-24. FDA classified it as Class II and gives the reason as "The Streamline Navigation System taps have experienced binding with other devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0300-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-24
Posted: 2020-10-27
Terminated: 2024-09-16
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: 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 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The Streamline Navigation System taps have experienced binding with other devices.
Root cause tag: design
FDA 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 in commerce: 420
Distribution: US Nationwide distribution including in the state of Michigan.
Product codes and lots: Lots 372816 377619 372817 372813 372927 373852 377616 377620 372926 372925 372923 372924 366798 367040 366799 370212 371729 377621 371730 373437 371731 372815 377622 373845 377623 369372 370853 377624

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0300-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0299-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-27
Z-0300-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-27

Product code OLO

K200095Class IIStreamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. / cleared 2020-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)