Class 2 Device Recall HARMONIC ACE7, Shears with Advanced Hemostasis

• Date Initiated by Firm: January 19, 2021
• Create Date: March 31, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1327-2021
• Recall Event ID: 87434
• 510(K)Number: K161693
• Product Classification: Scalpel, ultrasonic, reprocessed - Product Code NLQ
• 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.
• Code Information: Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: Marissa Richmond; 888-888-3433
• Manufacturer Reason for Recall: Product was distributed without receiving regulatory clearance.
• FDA Determined 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 of the following methods: a) Email: SSSPFA@stryker.com b. To their Recalling Firm's Sales Representative c. Fax: 480-763-5345 The form must be completed and returned to the Recalling Firm even if no affected product is found. 4. If any of the affected products have been forwarded to additional facilities, please contact these facilities and communicate this recall to them. 5. Maintain awareness of this communication internally until all required actions have been completed with their facility. If the returned Urgent Medical Device Business Reply Forms indicated that any affected products remains in customer's inventory, a Recalling Firm Representative will contact them to arrange for the removal of the product(s). Any questions regarding this Recall - contact Post Market Surveillance Manager at 888-888-3433 or email Marissa.richmond@stryker.com
• Quantity in Commerce: 102 units
• Distribution: Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NLQ and Original Applicant = STRYKER SUSTAINABILITY SOLUTIONS