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.
FDA Recall Z-0070-04 · Posted 2003-10-30
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Recalling FirmMisonix, Inc
Recall StatusTerminated
Product CodeLFL
Date Initiated2003-08-13
Date Terminated2005-02-07
Product Quantity1119 units (potentially)
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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, China, Taiwan ROC, and S. Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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