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

FDA device recall Z-2336-2010 · posted 2010-09-09 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corporation

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.

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

FWZ

Quantity affected

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.

Date initiated

2010-05-19

Date posted

2010-09-09

Date terminated

2011-10-27

Location

Cincinnati, OH