# FDA recall Z-1694-2021

> **Signature Orthopedics Pty Limited** · Class II · device recall initiated 2021-04-20.

## Product

Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

## Reason for recall

Product mislabeled, with the incorrect product inside the package.

## Distribution

US Nationwide distribution in the state of NC.

## Key facts

- **Recall number:** Z-1694-2021
- **Recalling firm:** Signature Orthopedics Pty Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-20
- **Report date:** 2021-06-09
- **Termination date:** 2023-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lane Cove West, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2021

## Citation

> AI Analytics. FDA recall Z-1694-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1694-2021. Source: US FDA. Licensed CC0.

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