# FDA recall Z-1018-2023

> **Biomet, Inc.** · Class II · device recall initiated 2022-12-15.

## Product

Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component  Item Number: 154341

## Reason for recall

Packaged in the incorrect shelf carton.   Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch  to be folded and packaged in the carton causing compound creases and compromise the sterile barrier

## Distribution

Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.

## Key facts

- **Recall number:** Z-1018-2023
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-15
- **Report date:** 2023-02-01

- **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-1018-2023

## Citation

> AI Analytics. FDA recall Z-1018-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1018-2023. Source: US FDA. Licensed CC0.

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