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.
This recall has been terminated (originally issued September 9, 2010).
- Company
- Integra Lifesciences Corporation
- Recall Initiated
- May 19, 2010
- Posted
- September 9, 2010
- Terminated
- October 27, 2011
- Recall Number
- Z-2336-2010
- Quantity
- 13 Units
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.
Lot / Code Info
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
Root Cause
Labeling mix-ups
Action Taken
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.