—#104989

Product

Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX 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: P0103111 P0105711 P0106011 P0200111 P0200211 P0201111 P0201611 P0201811 P0202011 P0202111 P0202911 P0203111 P0203411 P0203711 P0203811 P0204011 P0204211 P0204311 P0204411 P0204611 P0204711 P0204811 P0204911 P0205211 P0205411 P0205511 P0205711 P0205611 P0205811 P0205911 P0206211 P0206311 P0206411 P0210711 P0212911 P0213811 P0213911 P0300211 P0300411 P0300711 P0300911 P0301011 P0301411 P0301511 P0301711 P0301811 P0302111 P0302311 P0302411 P0302511 P0302611 P0302711 P0302811 P0303011 P0303111 P0303211 P0303311 P0303511 P0303611 P0303711 P0304011 P0304111 P0304311 P0304411 P0304611

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 #104989. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.