Stryker Sustainability Solutions Recall 87434
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.
Stryker Sustainability Solutions Recall 87434 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1327-2021 |
| Event ID | 87434 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel. |
| Quantity | 102 units |
| Recall Reason | Product was distributed without receiving regulatory clearance. |
| Device Classification | 20210407 |
| Device Code Info | Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050 |
| Center Classification Date | 20210331 |
| Recall Initiation Date | 20210119 |
| Recalling Firm | Stryker Sustainability Solutions |
| Initial Notification | Letter |
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