Z-0381-2012

UltraLite Headlight module-grey Model: 001328

Name: Z-0381-2012 UltraLite Headlight module-grey Model: 001328
Creator: Integra LifeSciences Corp.
Published: 2011-10-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-10-10 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light... on 2011-10-10. The reason FDA records is "Headlight assembly (module) may become loose and separate from the headband assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0381-2012
Status: Terminated
Initiated: 2011-10-10
Posted: 2012-01-11
Terminated: 2012-10-01
Recalling firm: Integra LifeSciences Corporation
Product: UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Product code: FST Light, Surgical, Fiberoptic
Reason for recall: Headlight assembly (module) may become loose and separate from the headband assembly
Root cause tag: design
FDA 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 in commerce: 60 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.
Product codes and lots: All serial numbers

Product code FST

K864380Class IILutex Headlight SystemsLuxtec Corp. / cleared 1986-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)