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Stryker Sustainability Solutions recalls Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis
Recalled April 7, 2021 · FDA recall Z-1327-2021 · Stryker Sustainability Solutions
Hazard
Product was distributed without receiving regulatory clearance. · FDA Class II
Units
102 units
Sold at
Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Description
Product was distributed without receiving regulatory clearance.
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.
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →