# FDA recall Z-1263-2023

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2023-02-15.

## Product

Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

## Reason for recall

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

## Key facts

- **Recall number:** Z-1263-2023
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-15
- **Report date:** 2023-03-29

- **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-1263-2023

## Citation

> AI Analytics. FDA recall Z-1263-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1263-2023. Source: US FDA. Licensed CC0.

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