# FDA recall Z-1000-2024

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2023-12-22.

## Product

HRIS ACET CUP CUT TIP 32X140   Part Number: 6210-5-200rker.    single-use, sterile surgical instruments used during hip arthroplasty

## Reason for recall

Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-1000-2024
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-22
- **Report date:** 2024-02-14

- **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-1000-2024

## Citation

> AI Analytics. FDA recall Z-1000-2024. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1000-2024. Source: US FDA. Licensed CC0.

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