# FDA recall Z-1327-2021

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2021-01-19.

## Product

Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.

## Reason for recall

Product was distributed without receiving regulatory clearance.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.

## Key facts

- **Recall number:** Z-1327-2021
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-19
- **Report date:** 2021-04-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2021

## Citation

> AI Analytics. FDA recall Z-1327-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1327-2021. Source: US FDA. Licensed CC0.

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