# FDA recall Z-0645-2022

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2021-12-21.

## Product

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

## Reason for recall

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

## Distribution

Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

## Key facts

- **Recall number:** Z-0645-2022
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-21
- **Report date:** 2022-02-23

- **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-0645-2022

## Citation

> AI Analytics. FDA recall Z-0645-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0645-2022. Source: US FDA. Licensed CC0.

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