Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Recall Z-2770-2015 · Posted 2015-09-16
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Recalling FirmLumenis
Recall StatusTerminated
Product CodeGCJ
Date Initiated2015-07-30
Date Terminated2018-05-25
Product Quantity54 devices with 108 hand pieces
Reason for Recall
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
Firm Action
Lumenis sent an Urgent Medical Device Recall letter on August 7, 2015, to all consignees. Consignees were instructed to destroy the operator manual, and return the affected device to Lumenis along with the completed Recall Verification form. Consignees with questions were instructed to call 801-656-2663.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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