Streamline MIS Navigation System Taps, Catalog Nos. 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 Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
- Recall Initiated
- September 24, 2020
- Posted
- October 27, 2020
- Terminated
- September 16, 2024
- Recall Number
- Z-0299-2021
- Quantity
- 420 units
- Firm Location
- Marquette, MI
Reason for Recall
The Streamline Navigation System taps have experienced binding with other devices.
Distribution
US Nationwide distribution including in the state of Michigan.
Lot / Code Info
Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
Root Cause
Device Design
Action Taken
On September 24, 2020, the firm distributed the Urgent Medical Devices Recall letter to customers. Customers were instructed to remove affected product from all user sites and inventory locations. These instrument systems are to be returned to RTI Surgical along with a completed copy of the response form. Accounts who have further distributed the affected products are also asked to immediately notify their customers by providing them a copy of the recall letter and the response form for completion when returning the affected devices to RTI Surgical.