PACK 9731975 TUMOR RESECTION AXIEM CR

FDA device recall Z-1589-2014 · posted 2014-05-09 · Terminated

Recall details

Recalling firm

Medtronic Navigation, Inc.

Reason for recall

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Action taken

Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HAW

Quantity affected

26,674 total

Distribution

Nationwide Distribution

Date initiated

2014-04-24

Date posted

2014-05-09

Date terminated

2014-12-29

Location

Louisville, CO

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