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U.S. Department of Health and Human Services

Class 2 Device Recall Mayfield Infinity XR2

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  Class 2 Device Recall Mayfield Infinity XR2 see related information
Date Initiated by Firm May 19, 2010
Date Posted September 09, 2010
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-2336-2010
Recall Event ID 55852
Product Classification Operating Room Accessories Table Tray - Product Code FWZ
Product Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.
Code Information Reference number A-2079, Serial number(s) XB091031, XB091032, XB091033, XB091034, XB091035, XB091036, XB091037, XB091038, XB091039, XB091040, XB091041, XB091042, XB091043, XB091044, XB091045, XB091046, XB091047, XB091048, XB091049, XB091050
Recalling Firm/
Manufacturer		 Integra LifeSciences Corporation
4900 Charlemar Dr Bldg A
Cincinnati OH 45227-1402
For Additional Information Contact
513-533-7923
Manufacturer Reason
for Recall		 Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Integra Life Sciences Corporation,contacted their customers via telephone and Field Correction Letter on May 19, 2010 to notify their customers of the problem. The firm indicated that their sales representatives will visit the consignees affected, correct the case labeles according to the specific instructions indicated, revise their account tracebility records to reflect the labeling change, then, sign and return the Acknowledgement of Reciept and Return Form for confirmation. For questions regarding the correction, please contact Integra Life Sciences Corporation at (877) 44-1114 or (513) 533-7923.
Quantity in Commerce 13 Units
Distribution Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.
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.
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