# FDA recall Z-0322-2021

> **RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)** · Class II · device recall initiated 2020-09-24.

## Product

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.

## Reason for recall

System does not include a drill guide.

## Distribution

Distributed to one distributor in Michigan.

## Key facts

- **Recall number:** Z-0322-2021
- **Recalling firm:** RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-24
- **Report date:** 2020-11-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marquette, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2021

## Citation

> AI Analytics. FDA recall Z-0322-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0322-2021. Source: US FDA. Licensed CC0.

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