BEUDAMED
    FDA Recall Open, Classified

    HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

    Recall: Z-2355-2021 · Initiated July 20, 2021

    Recall

    Recall Number
    Z-2355-2021
    Event Number
    88434
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    LFL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 20, 2021
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803

    Description

    HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

    Reason

    An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

    Action

    Ethicon issued Urgent Medical Device Removal letter to Operating Room Supervisors, Materials Management Personnel, and Chief of Surgery, on July 20, 2021. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product 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. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 877-884-7828 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Customers are required to return unused affected HARMONIC HD 1000i Shears subject to this recall that are in their inventory immediately. To receive replacement reimbursement, customers must return product subject to this recall no later than October 31, 2021. Any non-affected product and any product returned after the date specified will not receive replacement. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling 888-3

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.

    Quantity

    7870 units