Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
FDA device recall Z-0358-2012 · posted 2011-12-02 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FCW
- Quantity affected
- 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, Wash
- Date initiated
- 2011-10-14
- Date posted
- 2011-12-02
- Date terminated
- 2012-03-08
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUXTEC MLX LIGHT SOURCE (K081477) | Integra Luxtec, Inc. | 2008-06-18 |