Z-1327-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- January 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 units
Product Description
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 Pattern
Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Code Information
Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050