# FDA recall Z-1607-2024

> **Biomet, Inc.** · Class II · device recall initiated 2024-03-13.

## Product

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a  polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed  into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double  barrier system is placed into a paperboard carton with an IFU and label/indicator dots  applied to the carton.

## Reason for recall

Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

## Distribution

Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.

## Key facts

- **Recall number:** Z-1607-2024
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-13
- **Report date:** 2024-05-01

- **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-1607-2024

## Citation

> AI Analytics. FDA recall Z-1607-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1607-2024. Source: US FDA. Licensed CC0.

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