Class 2 Device Recall The HARMONIC ACE Shears Adaptive Tissue Technology

• Date Initiated by Firm: May 03, 2018
• Create Date: June 01, 2018
• Recall Status: Terminated on November 25, 2019
• Recall Number: Z-2049-2018
• Recall Event ID: 80066
• 510(K)Number: K121550
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• Product: HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447; ; Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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) and other open and endoscopic procedures.
• Code Information: N93923, N9392K, N93978, P9123A, P9129W, P91301, P91394, P9139N, P9144R, P9149J, P9148K, P9168K, P9173R, P9174K, P91795, P91C51, P91C83, P91D30, P91K68, P91L0H, P91K69, P91L0J, P91L1Y, P91L6E, P91L6J, P9396A, P9396C, P9399T, P93A1L, P93M0K, P93M0L, P93N01, P93M5Y, P93N5A, P93N3X, P93N3Y, P93P09, P93P26, P93P7H, P93R10, P93R4F, P93R4G, P93R56, P93R6V, P93T0X, P93T9L, P93T9M, P93U17, P93U91, P93V0V, P93V0W, P93V5T, P93V02, P93V03, P93X4E, P93X65, P93X85, P93X98, P93X9E, P93Y47, P93Y48, P93Y8X, P93X2X, P93Z95, P93Z4T, P93Z5X, P94015, P9405H, P9409W, P9410Z, P9414T, P94A5K, P94A6A, P94C11, P94C47, P94C5R, P94C8T, P94D3J, P94D3K, P94D5G, P94D7Z, P94D9K, P94E1Z, P94E20, P94E3Z, P94E8W, P94F1M, P94F3A, P94F5T, P94F6C, P94F7L, P94G1G, P94G1H, P94G1J, P94H0J, P94H0K, P94H31, P94H4V, P94H8J, P9139V, P91749, P9179U, P91F2X, P91L1Z, P93L47, P93L76, P93M6T, P93M6P, P93N00, P93N7G, P93N7H, P93P2E, P93P7G, P93R0Z, P93R57, P93R6U, P93T20, P93T26, P93U0P, P93U5N, P93U90, P93V57, P93W9X, P93X2G, P93W9R, P93X2W, P94C10, P94D0M, P94D0P, P94J29
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: Ann Leibson; 513-337-8180
• Manufacturer Reason for Recall: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
• FDA Determined Cause: Other
• Action: Urgent Voluntary Medical Device Recall (Removal) letters were distributed on 5/3/18. The letters included the following instructions for customers: 1. Examine your inventory immediately to determine if you have product lots subject to this recall on hand and quarantine such product(s). 2. Remove the product lots subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product lots subject to this recall have been forwarded to another facility, contact that facility to arrange return. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 1-866-913-0665 or ethicon5872@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall. 4. Keep this notice visibly posted for awareness until all product lots subject to this recall have been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product lots subject to this recall and keep a copy for your records. 5. Customers are required to return all unused HARMONIC ACE¿+ Shears with Adaptive Tissue Technology product lots subject to this recall that are in their inventory immediately. Only unused HARMONIC ACE¿+ Shears with Adaptive Tissue Technology product lots subject to this recall returned by August 31, 2018 will be eligible for replacement. Any unused HARMONIC ACE¿+Shears with Adaptive Tissue Technology product lots subject to this recall returned after August 31, 2018 will not be eligible for replacement. 6. To return unused HARMONIC ACE¿+ Shears with Adaptive Tissue Technology product lots subject to this recall, photocopy the completed BRF, place it in the box with the subject products, and affix the pre-paid authorized shipping label included with this recall notification letter. Ethicon wi
• Quantity in Commerce: 146,326
• Distribution: Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFL and Original Applicant = ETHICON ENDO-SURGERY, LLC