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

Pioneer Surgical Streamline OCT Navigated Instruments Recall: Missing Drill Guide

Pioneer Surgical Technology recalls Streamline OCT Navigated Instruments with catalog numbers 26-DRILL-MDN through 26-S-FINDER-MDN due to missing drill guide. This could lead to improper surgical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0322-2021Medical device Pioneer Surgical Technology ›

Lower-risk recall

System does not include a drill guide.

Take action

Contact the company

Recalling firmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)375 River Park Cir · Marquette, MI 49855-1781

✎ GovInfoNow plain-language explainer

Pioneer Surgical Technology is recalling Streamline OCT Navigated Instruments with specific catalog numbers because they do not include a drill guide. This missing component could lead to improper surgical procedures during use. Read more at govinfonow.com/recall/64219-pioneer-surgical-streamline-oct-navigated-instruments-recall-missing-drill-guide.

Source Summary by GovInfoNow · govinfonow.com/recall/64219-pioneer-surgical-streamline-oct-navigated-instruments-recall-missing-drill-guide · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0322-2021

Cite this page

“Pioneer Surgical Streamline OCT Navigated Instruments Recall: Missing Drill Guide.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64219-pioneer-surgical-streamline-oct-navigated-instruments-recall-missing-drill-guide. Based on FDA recall #Z-0322-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2021%22&limit=1).

The FDA announced on Sept. 24, 2020, that Pioneer Surgical Technology recalled Streamline OCT Navigated Instruments because the system does not include a drill guide. RTI Surgical, Inc., dba Pioneer Surgical Technology, initiated the voluntary Class II recall of 76 units distributed to one distributor in Michigan.

How to tell if you have it

Brand: Pioneer Surgical Technology
Product: Streamline OCT Navigated Instruments
Catalog numbers: 26-DRILL-MDN, 26-FTAP-30-MDN, 26-FTAP-35-MDN, 26-FTAP-40-MDN, 26-FTAP-45-MDN, 26-S-FINDER-MDN
Lot codes: 370855, 373847, 373848, 373849, 377629, 373850, 373846

The hazard

The recall hazard is that the Streamline OCT Navigated Instruments system does not include a drill guide. The FDA record provides no information regarding incidents or injuries associated with this defect.

Context

GovInfoNow's records show Pioneer Surgical Technology has three other recalls on record since Sept. 11, 2020. Other recent recalls of similar products include SEASPINE NorthStar OCT Navigation Guide (Nov. 17, 2025), Da Vinci Surgical System (Nov. 7, 2025), and Embrace Drill Tower Wedged (Feb. 11, 2026).

How to tell if you have this one

Check for catalog numbers 26-DRILL-MDN, 26-FTAP-30-MDN, 26-FTAP-35-MDN, 26-FTAP-40-MDN, 26-FTAP-45-MDN, and 26-S-FINDER-MDN on the instruments. These products were sold with specific lot numbers including 370855, 373847, 373848, 373849, 377629, 373850, and 373846.

Brand
Pioneer Surgical Technology
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Missing Drill Guide
Inspect the instruments for the presence of a drill guide. If missing, contact Pioneer Surgical Technology for further instructions.

Where it went and when

Where it was distributed

Distributed in Michigan.

FDA distribution: “Distributed to one distributor in Michigan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan.

Recall timeline

FDA published this recall 48 days after the firm started it.

Sep 24, 2020Firm started the recall
Nov 2, 2020FDA classified it Class II
Nov 11, 2020Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

More Pioneer Surgical Technology recalls

Link to this recall

<a href="https://govinfonow.com/recall/64219-pioneer-surgical-streamline-oct-navigated-instruments-recall-missing-drill-guide">Pioneer Surgical Streamline OCT Navigated Instruments Recall: Missing Drill Guide (GovInfoNow)</a>

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-0322-2021 (September 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0322-2021 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.