| Date Initiated by Firm |
May 02, 2011 |
| Date Posted |
June 17, 2011 |
| Recall Status1 |
Terminated 3 on March 26, 2014 |
| Recall Number |
Z-2585-2011 |
| Recall Event ID |
58837 |
| 510(K)Number |
K081459
|
| Product Classification |
Instrument, Ultrasonic Surgical Aspirator - Product Code LFL
|
| Product |
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.
|
| Code Information |
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 |
Recalling Firm/
Manufacturer |
Integra Limited
311 Enterprise Dr
Plainsboro NJ 08536-3344
|
| For Additional Information Contact |
Jon Caparotta
609-936-2495
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Device Design |
| 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. |
| Quantity in Commerce |
105 units |
| Distribution |
Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan |
| Total Product Life Cycle |
TPLC Device Report
|
|
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 = LFL and Original Applicant = INTEGRA RADIONICS, INC.
|
