Recall Z-2770-2015
Lumenis · initiated July 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2770-2015
- Initiated
- July 30, 2015
- Posted by FDA
- September 16, 2015
- Terminated
- May 25, 2018
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 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.
- Recalling firm
- Lumenis