Class 2 Device Recall Salient Surgical

• Date Initiated by Firm: July 18, 2011
• Date Posted: July 28, 2011
• Recall Status: Terminated on March 09, 2012
• Recall Number: Z-2892-2011
• Recall Event ID: 59377
• 510(K)Number: K052859
• Product: 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
• Code Information: Devices shipped between July 11, 2008 and July 14, 2011 S/N: TLF05800 TLF06800 TLF07800 TLG13800 TLH14800 TLH15800 TLH23800 TLH28800 TLH24800 TLH12800 TLH13800 TLH30800 TLI05800 TLJ08800 TLJ11800 TLJ21800 TLK05800 PHK06800 PHK08800 PHL01800 PHL03800 PHL04800 PHL05800 PHL06800 PHA30900 PHA3090A PHL0580A PHL0680A PHL0180A PHL0380A PHL0480A PHH14900 ST000590 ST000580 PHH25900 ST000600 ST000610 ST002350 ST002940 PHI30900 PHI17900 PHJ07900 ST000620 ST000630 PHJ19900 PHJ23900 PHK17900 ST000570 ST000640 PHK18900 ST000650 PHK30900 ST000660 PHL01900 PHL08900 PHL14900 PHL21900 PHA07000 ST002550 ST002560 ST003640 ST004260 PHB10000 ST004280 ST004290 ST004300 ST004310 PHA25000 PHB23000 ST004700 ST006570 ST005520 ST005510 ST006580 ST006590 ST006600 ST007570 ST007580 ST007590 ST009260 ST009280 PHD270J0 PHG300F0 ST009670 ST009680 ST010990 PHI130L0 ST011000 ST011010 ST012440 PHK120U0 PHL20000 ST014800 ST014820 ST014810 PHA221A0 ST014830 ST015600 ST015610 PHB18100 PHB241C0 ST016830 ST016840 ST016850 PHB241B0 ST017650 ST017660 ST017670 21113104 21113601 21114302 PHE13100 21116503 PHE31100 21116801 21117201
• Recalling Firm/ Manufacturer: Salient Surgical Technologies, Inc; 180 International Drive; Portsmouth NH 03801
• For Additional Information Contact: Martin j.Leighton; 603-294-5446
• Manufacturer Reason for Recall: Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 48, 963 units
• Distribution: Worldwide Distribution - USA (nationwide) and countries of China, Denmark, France, Germany, Greece, Italy, Japan, , South Africa, Spain, and Turkey.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code =