Z-2336-2010

Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD...

Name: Z-2336-2010 Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD...
Creator: Integra LifeSciences Corporation
Published: 2010-05-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-05-19 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corporation began a recall of Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating... on 2010-05-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2336-2010
Status: Terminated
Initiated: 2010-05-19
Posted: 2010-09-09
Terminated: 2011-10-27
Recalling firm: Integra LifeSciences Corporation
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.
Product code: FWZ Operating Room Accessories Table Tray
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)