FDA Recall Terminated

Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar Sealer is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization

Recall: Z-2892-2011 · Initiated July 18, 2011

Recall

Recall Number: Z-2892-2011
Event Number: 59377
Firm: Salient Surgical Technologies, Inc
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: July 18, 2011
Posted: July 28, 2011
Terminated: March 9, 2012
Address: 180 International Drive, Portsmouth, NH, 03801

Description

Reason

Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin

Action

Salient Surgical Technologies, Inc. sent an "URGENT MEDICAL DEVICE RECALL" notification letter dated July 18, 2011 to all affected customers and distributors. The letter describes the product, problem and the actions to be taken. The letter requested that customers and distributors immediately identify and discontinue use of all Aquamantys 2.3 Bipolar Sealer devices in inventory and quarantine them until they can be returned to Salient. The letter states that a Salient sales representative will arrange return of the recalled product to Salient. The letter provides information for customers about the replacement of the recalled product. If you have any questions, please contact Customer Service, at 866-777-9400, or your sales representative.

Distribution

Worldwide Distribution - USA (nationwide) and countries of China, Denmark, France, Germany, Greece, Italy, Japan, , South Africa, Spain, and Turkey.

Quantity

48, 963 units