RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Lot Codes / Batch Numbers
Lots 370855 373847 373848 373849 377629 373850 373846
Products Sold
Lots 370855 373847 373848 373849 377629 373850 373846
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26- due to System does not include a drill guide.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System does not include a drill guide.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MI
Page updated: Jan 10, 2026