FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
- Recall number
- Z-0358-2012
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
- 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
- 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.
- Lot, serial or model codes
- SN'S: P0102011 P0203911 P0204511 P0302011 P03011211 P0303411 P0104911 P0105211 P0105811 P0106611
- 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