# FDA recall Z-0941-2018

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2017-07-21.

## Product

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535

## Reason for recall

Inner and outer sterile barriers not fully sealed.

## Distribution

Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.

## Key facts

- **Recall number:** Z-0941-2018
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-21
- **Report date:** 2018-03-21
- **Termination date:** 2020-03-12

- **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-0941-2018

## Citation

> AI Analytics. FDA recall Z-0941-2018. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0941-2018. Source: US FDA. Licensed CC0.

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