Z-0358-2012

Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU

Name: Z-0358-2012 Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
Creator: Integra LifeSciences Corp.
Published: 2011-10-14
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-10-14 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU on 2011-10-14. The reason FDA records is "A loose screw may result in shifting of components and improper function of the turret or actuator assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0358-2012
Status: Terminated
Initiated: 2011-10-14
Posted: 2011-12-02
Terminated: 2012-03-08
Recalling firm: Integra LifeSciences Corporation
Product: Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
Product code: FCW Light Source, Fiberoptic, Routine
Reason for recall: A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 19
Distribution: 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.
Product codes and lots: SN'S: P0102011 P0203911 P0204511 P0302011 P03011211 P0303411 P0104911 P0105211 P0105811 P0106611

Product code FCW

K081477Class IILuxtec Mlx Light SourceIntegra Luxtec, Inc. / cleared 2008-06-18

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)