Z-0299-2021Class II

Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN...

Name: Z-0299-2021 Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-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 MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-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-0299-2021
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 MIS Navigation System Taps, Catalog Nos. 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 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 units
Distribution: US Nationwide distribution including in the state of Michigan.
Product codes and lots: Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0299-2021
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)