# FDA recall Z-3132-2024

> **Zimmer GmbH** · Class II · device recall initiated 2024-08-08.

## Product

Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components.  Item Number: 650-1066

## Reason for recall

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

## Distribution

Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.

## Key facts

- **Recall number:** Z-3132-2024
- **Recalling firm:** Zimmer GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-08
- **Report date:** 2024-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winterthur, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3132-2024

## Citation

> AI Analytics. FDA recall Z-3132-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-3132-2024. Source: US FDA. Licensed CC0.

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