Class 2 Device Recall Luxtec MLX 300 Watt Xenon Light Source

• Date Initiated by Firm: March 07, 2011
• Date Posted: April 25, 2011
• Recall Status: Terminated on March 26, 2014
• Recall Number: Z-2060-2011
• Recall Event ID: 58261
• 510(K)Number: K081477
• Product Classification: Light source, fiberoptic, routine - Product Code FCW
• Product: Luxtec¿ MLX 300 Watt Xenon Light Source,; Model OOMLX; Surgical/Medical Light Source; ; ; This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.
• Code Information: Serial numbers: 031009 0416410 035709 023210 102109 053510 126709 039810 0310710 0411210 057910 034910 065010 044110 064310 117209 602319 062010 022010 113009 090408 043510 117409 093108 051709 086908 118509 032510 057810 083109 043810 082708 030910 061408 054710 061310 084009 106509 053009 060110 412110 021709 033409 051109 072309 073708 080808 083408 084208 084808 092808 100808 104008 021809 071908 022609 070208 093208 103609 105609 105809 110309 110609 110709 110809 110909 111009 111109 111309 083208 090808 120308 010909 022709 075108 101209 104509 105109 106409 107809 108009 036509 122008 075208 010509 036009 061909 085209 073308 040309 031209 102309 062409 036709 122808 040709 121908 093608 101108 123308 051609 040909 010909 036209 127209 061509 106809 121808 040809 033910 036409 040209 103109 103708 121009 040909 034410 033710 122009 073809 113009 041160 076408 117409 060309 116709 075609 115009 117609 116309 074209 022309 043610 042710 032210 118709 035110 and 023410 057410 030710 116109 032310 073309 and 1110109
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: May Sayco; 609-936-6824
• Manufacturer Reason for Recall: Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.
• FDA Determined Cause: Process change control
• Action: Integra notified all customers/distributors via written communication, dated 3/08/2011. On 3/09/11, Integra Sales Representatives and Service Technicians were notified via telephone conference call and provided copies of written communications. Customers were advised to immediately discontinue use of any affected product and to place in a secure area. Note: This defect only applies to MLX units that were repaired between 12/01/2009 and 1/31/2011. This defect does not occur in manufactured units that have not been serviced, nor does it apply to MLX units that were serviced outside of this specific timeframe. Customers with devices already known to require repair and/or servicing will be contacted directly to arrange for the return of their device(s). Additionally, sales specialists were instructed to examine each customer's inventory for those device(s) that may potentially have the jumper-wire and to perform a stand-by test to determine if repair and/or servicing are required.
• Quantity in Commerce: 159 units
• Distribution: Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden
• 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.