Z-0322-2021Class II

Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN...

Name: Z-0322-2021 Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-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 / Open, Classified / root cause: design

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of 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... on 2020-09-24. FDA classified it as Class II and gives the reason as "System does not include a drill guide". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0322-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-24
Posted: 2020-11-02
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: 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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: System does not include a drill guide.
Root cause tag: design
FDA 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 in commerce: 76 units
Distribution: Distributed to one distributor in Michigan.
Product codes and lots: Lots 370855 373847 373848 373849 377629 373850 373846

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0322-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0322-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-11	2020-11-02

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)