Device 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.
Z-1327-2021
Product summary
- Event
- Event 87434
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 102 units
- Official record key
device-enforcement:Z-1327-2021
Official wording
Reason: Product was distributed without receiving regulatory clearance.
Code information: Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Derived failure modes
-
Unknown
Product was distributed without receiving regulatory clearance.