# FDA recall Z-2025-2021

> **Tornier, Inc** · Class II · device recall initiated 2021-05-28.

## Product

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile   Manufacturer Tornier SAS - Saint Martin, France.  Shoulder prosthesis component.

## Reason for recall

Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

## Distribution

IL and TX  Belgium, France and United Kingdom

## Key facts

- **Recall number:** Z-2025-2021
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-28
- **Report date:** 2021-07-21
- **Termination date:** 2023-04-14

- **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-2025-2021

## Citation

> AI Analytics. FDA recall Z-2025-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2025-2021. Source: US FDA. Licensed CC0.

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