# FDA recall Z-2298-2018

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2018-05-22.

## Product

LFIT Anatomic CoCr Femoral Heads,  Catalog No. 6260-9-336

## Reason for recall

The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.

## Distribution

Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-2298-2018
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-22
- **Report date:** 2018-07-11
- **Termination date:** 2020-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2298-2018

## Citation

> AI Analytics. FDA recall Z-2298-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2298-2018. Source: US FDA. Licensed CC0.

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