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U.S. Department of Health and Human Services

Class 2 Device Recall Integra LifeSciences

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  Class 2 Device Recall Integra LifeSciences see related information
Date Initiated by Firm October 14, 2011
Date Posted December 02, 2011
Recall Status1 Terminated 3 on March 08, 2012
Recall Number Z-0357-2012
Recall Event ID 60300
510(K)Number K081477  
Product Classification Light source, fiberoptic, routine - Product Code FCW
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.
Code Information SN'S: P0102211 P0102311 P0104611 P0104811 P0105011 P0105311 P0105411 P0105511 P0105911 P0106511 P0100311
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-275-0500
Manufacturer Reason
for Recall		 A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FCW and Original Applicant = INTEGRA LUXTEC, INC.
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