# FDA recall Z-0538-2018

> **Exactech, Inc.** · Class II · device recall initiated 2017-10-09.

## Product

Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5      All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

## Reason for recall

Wrong device description of the label identifying the implant

## Distribution

US Distribution to the states of :  AL, CA, CO, FL, MD. and NY

## Key facts

- **Recall number:** Z-0538-2018
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-09
- **Report date:** 2018-02-14
- **Termination date:** 2019-08-06

- **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-0538-2018

## Citation

> AI Analytics. FDA recall Z-0538-2018. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0538-2018. Source: US FDA. Licensed CC0.

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