# FDA recall Z-2567-2018

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2017-12-21.

## Product

Custom Made Implant System with Minimum Invasive Grower (MIG) component

## Reason for recall

From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.

## Distribution

NY, FL, KS

## Key facts

- **Recall number:** Z-2567-2018
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-21
- **Report date:** 2018-08-08
- **Termination date:** 2018-10-05

- **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-2567-2018

## Citation

> AI Analytics. FDA recall Z-2567-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2567-2018. Source: US FDA. Licensed CC0.

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