Z-2770-2015 Class II Terminated
FDA device recall Z-2770-2015 was initiated by Lumenis on July 30, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 25, 2018). Affected quantity: 54 devices with 108 hand pieces.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- July 30, 2015
- Termination Date
- May 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 devices with 108 hand pieces
Product Description
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.
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.
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.
Code Information
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.