Recall Z-2585-2011 ยท LFL Instrument, Ultrasonic Surgical
Integra Limited
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 sur
| Date | Jun 17, 2011 (initiated May 2, 2011) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 105 units |
| Distribution | Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM Integra Radionics, Inc., Aug 13, 2008 |