Z-0320-2021 Class II Terminated
FDA device recall Z-0320-2021 was initiated by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) on September 11, 2020 and is designated Class II. Reason for recall: The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve. The recall status is terminated (terminated May 23, 2024). Affected quantity: 143 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- September 11, 2020
- Termination Date
- May 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 143 units
Product Description
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
Reason for Recall
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
Distribution Pattern
Product distributed to Surgalign, a distributor located in Michigan.
Code Information
Lot numbers 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733