# FDA recall Z-2348-2021

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2021-07-01.

## Product

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty   Part Number: 1512-16-080

## Reason for recall

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

## Distribution

International distribution in the countries of Canada, France.

## Key facts

- **Recall number:** Z-2348-2021
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-01
- **Report date:** 2021-09-01
- **Termination date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2021

## Citation

> AI Analytics. FDA recall Z-2348-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2348-2021. Source: US FDA. Licensed CC0.

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