# FDA recall Z-1769-2026

> **Tornier, Inc** · Class II · device recall initiated 2026-03-05.

## Product

Tornier HRS Max parts:    1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101    2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102    3. TORNIER HRS Max Trial, Cat. No. ARS10252

## Reason for recall

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

## Distribution

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI.

## Key facts

- **Recall number:** Z-1769-2026
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-05
- **Report date:** 2026-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1769-2026

## Citation

> AI Analytics. FDA recall Z-1769-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1769-2026. Source: US FDA. Licensed CC0.

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