FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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.
- Recall number
- Z-0357-2012
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Status
- Terminated
- Initiated
- 2011-10-14
- Posted
- 2011-12-02
- Terminated
- 2012-03-08
- Reason
- A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- 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
- 12
- 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.
- Lot, serial or model codes
- SN'S: P0102211 P0102311 P0104611 P0104811 P0105011 P0105311 P0105411 P0105511 P0105911 P0106511 P0100311
- 510(k) numbers
- ["K081477"]
- PMA numbers
- not on file
- Product code
- FCW
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28