# FDA recall Z-1512-2018

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2018-01-12.

## Product

Knee Prosthesis, Sterile, Single-Use devices    Product Usage:  The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

## Reason for recall

Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

## Distribution

Affected products were sent to three medical facilities.  Affected product will be returned to the manufacturer for disposition.

## Key facts

- **Recall number:** Z-1512-2018
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-05-02
- **Termination date:** 2020-05-07

- **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-1512-2018

## Citation

> AI Analytics. FDA recall Z-1512-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1512-2018. Source: US FDA. Licensed CC0.

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