# FDA recall Z-3309-2024

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

## Product

Stryker Tornier Perform Humeral System,  Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

## Reason for recall

Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3309-2024
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-29
- **Report date:** 2024-10-09

- **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-3309-2024

## Citation

> AI Analytics. FDA recall Z-3309-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-3309-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*