Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
FDA device recall Z-2156-2014 · posted 2014-08-07 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
- Action taken
- The firm sent Medical Device Upgrade Notification letters dated July 11, 2014 to their customers.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 2,460 units
- Distribution
- Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, O
- Date initiated
- 2014-06-24
- Date posted
- 2014-08-07
- Date terminated
- 2015-10-27
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR (K010309) | Mutoh America Co., Ltd. | 2001-04-18 |