Recall Z-2484-2018 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Stryker Sustainability Solutions
Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis 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 scalpel
| Date | May 8, 2018 |
| Status | Terminated |
| Reason | Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used. |
| Root cause | Device Design |
| Action | Firm notified sales reps via email on 5/8/18 and instructed to have the customers complete response forms. |
| Quantity | 180 units |
| Distribution | US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis Stryker Sustainability Solutions, Feb 23, 2017 |