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 Initiated
- September 11, 2020
- Terminated
- May 23, 2024
- Recall Number
- Z-0320-2021
- Quantity
- 143 units
- Firm Location
- Marquette, MI
Reason for Recall
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Distribution
Product distributed to Surgalign, a distributor located in Michigan.
Lot / Code Info
Lot numbers 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
Root Cause
Device Design
Action Taken
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.