Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Streamline OCT Navigated Instruments Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Due to System does not include a drill guide.

Date: September 24, 2020
Company: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) directly.

Affected Products

Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.

Quantity: 76 units

Why Was This Recalled?

System does not include a drill guide.

Where Was This Sold?

Distributed to one distributor in Michigan.

About RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) has 50 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report