Z-0320-2021Class II

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

Name: Z-0320-2021 Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN...
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2020-09-11
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2020-09-11 / Terminated / root cause: design

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of 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... on 2020-09-11. FDA classified it as Class II and gives the reason as "The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve". 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-0320-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-11
Posted: 2020-10-31
Terminated: 2024-05-23
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: 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
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Root cause tag: design
FDA 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) were requested to be removed from the field. Please see RES 86559 for details on the September 24, 2020, recall. Customers are asked to do the following: -Remove all affected product from user sites and inventory locations -Return affected product to RTI Surgical, using RGA number - 63000897, along with a completed copy of the Acknowledgement and Receipt Form -Immediately notify any of your customers who have received the affected devices by providing them with a copy of the recall letter and response form for completion when returning affected devices.
Quantity in commerce: 143 units
Distribution: Product distributed to Surgalign, a distributor located in Michigan.
Product codes and lots: Lot numbers 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-0320-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0320-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-10-31

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)