Z-2770-2015Class II

Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is...

Name: Z-2770-2015 Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is...
Creator: Lumenis
Published: 2015-07-30
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2015-07-30 / Terminated / root cause: design

FDA source

Lumenis began a recall of Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic... on 2015-07-30. FDA classified it as Class II and gives the reason as "There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2770-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-30
Posted: 2015-09-16
Terminated: 2018-05-25
Recalling firm: Lumenis Ltd
Product: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 54 devices with 108 hand pieces
Distribution: 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.
Product codes and lots: GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2770-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2770-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-16

Product code GCJ

K133272Class IIVersacut + Tissue MorcellatorLumenis, Ltd. / cleared 2014-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)