# FDA recall Z-1043-2023

> **Biomet, Inc.** · Class II · device recall initiated 2022-12-29.

## Product

(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122   EXPANDED RECALL:  (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124  (3)	Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number:  183126

## Reason for recall

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

## Distribution

International distribution to the countries of: Argentina, China, Costa Rica, India,  Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand.   Expanded Recall US states of: FL, IN, MD, OH, PA, WI

## Key facts

- **Recall number:** Z-1043-2023
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-29
- **Report date:** 2023-02-08

- **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-1043-2023

## Citation

> AI Analytics. FDA recall Z-1043-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1043-2023. Source: US FDA. Licensed CC0.

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