Z-0299-2021 Class II Terminated
FDA device recall Z-0299-2021 was initiated by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) on September 24, 2020 and is designated Class II. Reason for recall: The Streamline Navigation System taps have experienced binding with other devices. The recall status is terminated (terminated September 16, 2024). Affected quantity: 420 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 24, 2020
- Termination Date
- September 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 units
Product Description
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.
Reason for Recall
The Streamline Navigation System taps have experienced binding with other devices.
Distribution Pattern
US Nationwide distribution including in the state of Michigan.
Code Information
Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733