FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
- Recall number
- Z-0375-2012
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
- Status
- Terminated
- Initiated
- 2011-10-10
- Posted
- 2012-01-11
- Terminated
- 2012-10-01
- 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 Customer Service at 1-800-431-1123.
- Quantity
- 2800 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, 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.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K864380"]
- PMA numbers
- not on file
- Product code
- FST
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28