Recall Z-1522-2014 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
| Date | Apr 29, 2014 (initiated Mar 10, 2014) |
| Status | Terminated |
| Reason | Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert. |
| Root cause | Under Investigation by firm |
| Action | Integra sent an Urgent: Voluntary Medical Device Recall letter dated March 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. Integra is asking that you do the following: 1. Review your unused inventory of 23 kHz CUSA Sterile Torque Wrenches and determine if they are on the affected lot number list on the next page and if they are still in the box. 2. Complete the attac |
| Quantity | 3,984 devices packaged as 6 devices / box (664 boxes) |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM Valleylab, Inc., Jul 6, 1998 |