Events

Recall of Device Recall Integra CUSA Selector NXT Ultrasonic Surgical Aspirator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58837
  • Event Risk Class
    Class 2
  • Event Number
    Z-2585-2011
  • Event Initiated Date
    2011-05-02
  • Event Date Posted
    2011-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100406
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, Ultrasonic Surgical Aspirator - Product Code LFL
  • Reason
    The insulated covering of a wire cable that powers the vacuum pump in the cusa nxt service module can become abraded over time resulting in the exposure of bare wire. if this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration.
  • Action
    Integra sent a "FIELD ACTION NOTIFICATION" dated May 2, 2011 to all affected customers. The letter identified the product, the problem and the actions to be taken. Customers were informed of a Field Corrective Action that is being initiated. All devices (customer owned, Integra Loaner Pool, and Sales demos) will undergo rework of the vacuum pump assembly. The rework will be scheduled, at customer sites by Integra Field Service Technicians or returned to a designated Integra Service Center for rework. A loaner will be presented to customer accounts upon request. The letter asks that each customer complete and return the enclosed Recall Acknowledgement and Return Form to Integra, maintaining a copy of the letter and form for your records. For any additional information please call 609-936-2485.

Device

Device Recall Integra CUSA Selector NXT Ultrasonic Surgical Aspirator
  • Model / Serial
    Serial Numbers: NBF1001601IE NBA1000501IE NBA1100901IE  NBA1101001IE NBA1102701IE  NBA1102801IE NBC1001501IE NBC1002001IE NBC1002301IE NBC1002901IE NBD1000101IE NBE1001301IE NBF1000701IE NBF1001101IE  NBG1001001IE NBG1001201IE NBJ1002401IE NBL0901901IE NBL0902101IE NBL0902501IE NCE1001901IE NCF1002201IE NCG1000201IE NCG1001401IE NCG1001501IE NXT1001 NXT1002 NXT1003 NXT1004 NXT1005 NXT1006 NXT1007 NXT1008 NXT1009 NXT1010 NXT1011 NXT1012 NXT1013 NXT1014 NXT1015 NXT1016 NXT1017 NXT1018 NXT1019 NXT1020P NXT1021 NXT1022 NXT1023 NXT1024 NXT1025 NXT1026 NXT1027 NXT1028 NXT1029 NXT1030 NXT1031 NXT1032 NXT1033 NXT1034 NXT1035 NXT1036 NXT1037 NXT1038 NXT1039 NXT1040 NXT1041 NXT1042 NXT1043 NXT1044 NXT1045 NXT1046 NXT1047 NXT1048 NXT1049 NXT1050 NXT1051 NXT1052 NXT1053 NXT1054 NXT1055 NXT1056 NXT1057 NXT1058 NXT1059 NXT1060 NXT1061 NXT1062 NXT1063 NXT1064 NXT1065 NXT1066 NXT1067 NXT1068 NXT1069 NXT1070 NXT1071 NXT1072 NXT1073 (Asia) NXT1074 NXT1075 NXT1076 NXT1077 NXT1078 NXT1079 NXT1080
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan
  • Product Description
    Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module || The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery.
  • Manufacturer
    Integra Limited

Manufacturer

Integra Limited
  • Manufacturer Address
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA