# FDA recall Z-3155-2024

> **Tornier, Inc** · Class II · device recall initiated 2024-08-29.

## Product

stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder

## Reason for recall

One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).

## Distribution

US Nationwide distribution in the states of IL, WI, AZ, NV, SD.

## Key facts

- **Recall number:** Z-3155-2024
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-29
- **Report date:** 2024-09-25

- **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-3155-2024

## Citation

> AI Analytics. FDA recall Z-3155-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3155-2024. Source: US FDA. Licensed CC0.

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