Harmonic recallZ-2356-2021 · Ethicon Endo-Surgery Inc · initiated Jul 20, 2021

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number

Z-2356-2021

Status

Open, Classified

Initiated by the company

Jul 20, 2021

Recalling firm

Ethicon Endo-Surgery Inc

Quantity

68960 units

Product code

LFL

FDA submissions

K191555

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.

Product description

HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Harmonic HARHD36

  Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical
  1 recall2 deaths5,037 reports

Product lines

• HarmonicEthicon Endo-Surgery, LLC · 13 models · 8,752 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 88434).

• Z-2355-2021 · 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