# FDA recall Z-0632-2022

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2022-01-05.

## Product

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries  Product Number: 154706001

## Reason for recall

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

## Distribution

US Nationwide distribution in the states of TN, TX.

## Key facts

- **Recall number:** Z-0632-2022
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-05
- **Report date:** 2022-02-16
- **Termination date:** 2023-12-22

- **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-0632-2022

## Citation

> AI Analytics. FDA recall Z-0632-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0632-2022. Source: US FDA. Licensed CC0.

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