Recall Z-2049-2018 ยท LFL Instrument, Ultrasonic Surgical
Ethicon Endo-Surgery Inc
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 scalp
| Date | May 3, 2018 |
| Status | Terminated |
| Reason | The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. |
| Root 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 arran |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY Ethicon Endo-Surgery, LLC, Aug 22, 2012 |