—#105222

Product

Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.

FDA product code: FCW — Light Source, Fiberoptic, Routine
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K081477
Affected lot / code info: SN'S: P0102211 P0102311 P0104611 P0104811 P0105011 P0105311 P0105411 P0105511 P0105911 P0106511 P0100311

Why it was recalled

A loose screw may result in shifting of components and improper function of the turret or actuator assembly.

Root cause (FDA determination)

Process control

Action the firm took

Integra sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx. The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s). If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form. For questions call Integra Surgical Customer Service at 1-800-431-1123.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of: Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of: Australia, Germany, Italy, Japan, Netherlands, New Zealand, Pakistan, Sweden, Switzerland, and Turkey.

Timeline

Recall initiated: 2011-10-14
Posted by FDA: 2011-12-02
Terminated: 2012-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.