Events

Recall of Device Recall HARMONIC ACE Shears Adaptive Tissue Technology

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80066
  • Event Risk Class
    Class 2
  • Event Number
    Z-2048-2018
  • Event Initiated Date
    2018-05-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164338
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, ultrasonic surgical - Product Code LFL
  • Reason
    The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
  • 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

Device

Device Recall HARMONIC ACE Shears Adaptive Tissue Technology
  • Model / Serial
    P9125C,  P93T5J,  P93T5K,  P93V06,  P93W4Y,  P93Y4A,  P93W8A, P9400F,  P9409V,  P94A93,  P94A94,  P94C8R,  P94G1W,  P91F4A,  P91F86,  P93M3W,  P93W0A,  P93Z4X,  P93Z96,  P94E6U,  P94H32,  P94H9V,  P94J28
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • 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.
  • Product Description
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 || 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.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA