# FDA recall Z-1419-2022

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2022-06-29.

## Product

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant  Part Number: 254400525

## Reason for recall

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring.  has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis,  Poor Joint Mechanics, Soft Tissue Irritation, Pain

## Distribution

Nationwide  Foreign:  Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

## Key facts

- **Recall number:** Z-1419-2022
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-29
- **Report date:** 2022-07-27

- **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-1419-2022

## Citation

> AI Analytics. FDA recall Z-1419-2022. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1419-2022. Source: US FDA. Licensed CC0.

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