FDA Device

Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.

Hazard

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

What You Should Do

Remedy

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.

Products

Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for s
Brand
Integra LifeSciences Corp.
UPC
All serial numbers

Units Affected

2181 units