Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
This recall has been terminated (originally issued December 2, 2011).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- October 14, 2011
- Posted
- December 2, 2011
- Terminated
- March 8, 2012
- Recall Number
- Z-0358-2012
- Quantity
- 19
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
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 / Code Info
SN'S: P0102011 P0203911 P0204511 P0302011 P03011211 P0303411 P0104911 P0105211 P0105811 P0106611
Root Cause
Process control
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.