FDAClass IINovember 11, 2020

Streamline OCT Navigated Instruments recall

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…

Why was Streamline OCT Navigated Instruments recalled?

System does not include a drill guide.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots 370855 373847 373848 373849 377629 373850 373846

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…
Recalling firm
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Quantity
76 units
Distribution
Distributed to one distributor in Michigan.
Recall date
November 11, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls