Recalls / —

—#105223

Product

Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU

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: P0102011 P0203911 P0204511 P0302011 P03011211 P0303411 P0104911 P0105211 P0105811 P0106611

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 #105223. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.