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Lower risk Medical device recall · FDA · Published September 24, 2020

Pioneer Surgical Streamline TL Navigation System: Binding with Other Devices

Pioneer Surgical recalls Streamline TL Navigation System devices with specific catalog numbers due to binding issues that may affect spinal surgery procedures.

🇺🇸 FDA recall #Z-0300-2021Medical devicePioneer Surgical ›
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Recalling firmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)375 River Park Cir · Marquette, MI 49855-1781
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pioneer Surgical is recalling Streamline TL Navigation System devices with specific catalog numbers because they can bind with other surgical devices. This could cause problems during spinal surgery procedures. Read more at govinfonow.com/recall/64181-pioneer-surgical-streamline-tl-navigation-system-binding-with-other-devices.

Source Summary by GovInfoNow · govinfonow.com/recall/64181-pioneer-surgical-streamline-tl-navigation-system-binding-with-other-devices · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0300-2021

Cite this page

“Pioneer Surgical Streamline TL Navigation System: Binding with Other Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64181-pioneer-surgical-streamline-tl-navigation-system-binding-with-other-devices. Based on FDA recall #Z-0300-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0300-2021%22&limit=1).

Why it’s dangerous

The Streamline Navigation System taps can bind with other surgical devices during spinal procedures. This binding may cause the system to malfunction, potentially affecting the precision of screw placement and anatomical structure identification.

Who’s affected

Surgical teams using the Streamline TL Navigation System for spinal procedures are most at risk if the system binds with other devices during surgery.

How to tell if you have this one

Check for catalog numbers 02-C-TAP-55-MDN, 02-C-TAP-60-L-MDN, 02-C-TAP-65-L-MDN, 02-C-TAP-65-MDN, and other listed numbers on the device packaging or documentation.

  • Brand
    Pioneer Surgical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution including in the state of Michigan.
Recall numberProduct, codes & lotsQuantity
Z-0299-2021Streamline 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.; Lots 377520 371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733420 units
Z-0300-2021Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FINDER-L-MDN 02-SFINDER-MDN 02-S-FINDER-T-MDN 02-TAP-45-MDN 02-TAP-55-MDN 02-TAP-60-L-MDN 02-TAP-65-L-MDN 02-TAP-65-MDN 02-TAP-75-L-MDN 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-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.; Lots 372816 377619 372817 372813 372927 373852 377616 377620 372926 372925 372923 372924 366798 367040 366799 370212 371729 377621 371730 373437 371731 372815 377622 373845 377623 369372 370853 377624420
Based on the official FDA remedy

What to do — step by step

  1. Check Device Catalog Number

    Look for the specific catalog numbers listed in the recall notice on the device packaging or documentation.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution including in the state of Michigan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 4 years after the firm started it.

1. Firm started the recall: Sep 24, 202012. FDA classified it Class II: Oct 27, 202023. Published in FDA’s Enforcement Report: Nov 4, 202034. FDA terminated the recall: Sep 16, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0300-2021 (September 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0300-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA