FDA Medical Device Recalls (openFDA)
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 number
- Z-0320-2021
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Product
- 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
- Status
- Terminated
- Initiated
- 2020-09-11
- Posted
- not on file
- Terminated
- 2024-05-23
- Reason
- The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 143 units
- Distribution
- Product distributed to Surgalign, a distributor located in Michigan.
- Lot, serial or model codes
- Lot numbers 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733
- 510(k) numbers
- ["K200095"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 1000115331
- Firm city
- Marquette
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28