Recall Z-0376-2012 ยท FST Light, Surgical, Fiberoptic
Integra LifeSciences Corp.
Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
| Date | Jan 11, 2012 (initiated Oct 10, 2011) |
| Status | Terminated |
| Reason | Headlight assembly (module) may become loose and separate from the headband assembly |
| Root cause | Device Design |
| Action | Integra Life Sciences notified consignees by URGENT DEVICE RECALL letter dated October 10, 2011, via FedEx, email or telephone conference calls. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to identify and return any affected product. Customers were requested to complete and return the attached Field Corrective Action Acknowledgement Form to Integra Surgical indicating receipt and review of this notification. For assistance and additional information contact your local and Integra Sales Representative or call Integra Surgical |
| Quantity | 198 units |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of: Africa, Algeria, Australia, Austria, Brazil, Canada, Check Republic, China, Chile, Costa Rica, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece Hungary, Guatemala, India, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864380 | LUTEX HEADLIGHT SYSTEMS Luxtec Corp., Nov 19, 1986 |