# FDA recall Z-2250-2021

> **Exactech, Inc.** · Class II · device recall initiated 2021-06-29.

## Product

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00.  Hip prosthesis component.

## Reason for recall

Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2250-2021
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-06-29
- **Report date:** 2021-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2021

## Citation

> AI Analytics. FDA recall Z-2250-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2250-2021. Source: US FDA. Licensed CC0.

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