Recall Z-2356-2021 ยท LFL Instrument, Ultrasonic Surgical
Ethicon Endo-Surgery Inc
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
| Date | Jul 20, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| 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 forwa |
| Quantity | 68960 units |
| 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, Leban |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length Ethicon Endo-Surgery, LLC, Feb 28, 2020 |