# FDA recall Z-0288-2021

> **Blue Ortho** · Class II · device recall initiated 2020-09-10.

## Product

Instructions For Use document of the GPS Trackers.

## Reason for recall

Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.

## Distribution

Domestic Distribution Only: CA, CO, SC and WI.

## Key facts

- **Recall number:** Z-0288-2021
- **Recalling firm:** Blue Ortho
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-10
- **Report date:** 2020-11-04
- **Termination date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gieres, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2021

## Citation

> AI Analytics. FDA recall Z-0288-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0288-2021. Source: US FDA. Licensed CC0.

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