# FDA recall Z-1042-2023

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

## Product

(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104  (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm  Item Number: 183106  (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm  Item Number: 183108  (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm  Item Number: 183110  (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm  Item Number: 183112

## 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-1042-2023
- **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-1042-2023

## Citation

> AI Analytics. FDA recall Z-1042-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1042-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*