# FDA recall Z-0418-2026

> **Zimmer, Inc.** · Class II · device recall initiated 2025-09-26.

## Product

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis

## Reason for recall

Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.

## Distribution

US:  OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS

## Key facts

- **Recall number:** Z-0418-2026
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-26
- **Report date:** 2025-11-12

- **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-0418-2026

## Citation

> AI Analytics. FDA recall Z-0418-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0418-2026. Source: US FDA. Licensed CC0.

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