Recall Z-1327-2021 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Stryker Sustainability Solutions
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, gynecolo
| Date | Jan 19, 2021 |
| Status | Open, Classified |
| Reason | Product was distributed without receiving regulatory clearance. |
| Root cause | Device Design |
| Action | On 01/19/2021, the firm sent an "URGENT; MEDICAL DEVICE RECALL" Notification letter its customers informing them that the affected products are currently under evaluation and do not have Regulatory Clearance and the safety and efficacy of the product has not been assessed. Customers are instructed to: 1. Discontinue use of the affected products. 2. Check their inventory for the affected products. 3. Complete the Urgent Medical Device Recall Business Reply Form and indicate if any of the affected product remains in their inventory. They are instructed to return the completed form through on o |
| Quantity | 102 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis Stryker Sustainability Solutions, Feb 23, 2017 |