# FDA recall Z-0940-2018

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

## Product

Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737

## 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-0940-2018
- **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-0940-2018

## Citation

> AI Analytics. FDA recall Z-0940-2018. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0940-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*