Recall Z-0070-04 ยท LFL Instrument, Ultrasonic Surgical
Misonix, Inc
LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present.
| Date | Oct 30, 2003 (initiated Aug 13, 2003) |
| Status | Terminated |
| Reason | Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe. |
| Root cause | Other |
| Action | Misonix, Inc. notified the sole direct consignee, Byron Medical Inc., of the "Corrective Action" by letter on 8/13/03. On 9/17/03, Byron Medical Inc. notified the end users by letter, and provided instructions for proper assembly and warning labels to be affixed to the units. |
| Quantity | 1119 units (potentially) |
| Distribution | 1 distributor in Tucson, AZ, for further distribution to end users (physicians and medical facilities) nationwide & Puerto Rico, and in the following countries: Canada, Mexico, Australia, Switzerland, Israel, Saudi Arabia, Cyprus, Greece, Turkey, Germany, Dominican Republic, Sweden, Netherlands, Chi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933559 | ALLIGER ULTRASONIC SURGICAL SYSTEM Medsonic, Inc., Oct 15, 1993 |