RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

IN, MI