Terminated

Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.

FDA Recall Z-0378-2012 · Posted 2012-01-11

Recalling FirmIntegra LifeSciences Corp.

Recall StatusTerminated

Product CodeFST

Date Initiated2011-10-10

Date Terminated2012-10-01

Product Quantity90 units

Reason for Recall

Headlight assembly (module) may become loose and separate from the headband assembly

Firm 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 Customer Service at 1-800-431-1123.

Root Cause

Device Design

Distribution Pattern

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, Ireland, Israel, Italy, Iraq, Japan, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Macedonia, Mexico, Netherlands, New Zealand! Norway, Oman, Pakistan, Peru Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Qatar, United Kingdom, Yemeni United Arab Emirates, Uruguay, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864380LUTEX HEADLIGHT SYSTEMSLuxtec Corp. · 1986-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.