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Terminated

SHUNT KIT 9733605 NON-INVASIVE

FDA Recall Z-1594-2014 · Posted 2014-05-09

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2014-04-24
Date Terminated2014-12-29
Product Quantity26,674 total

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.

Firm Action

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

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033621NDI PASSIVE SPHERESNorthern Digital, Inc. · 2004-01-27K022074SPHERZI.Z.I. Corp. · 2002-08-13K012937KNEE MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies · 2002-01-25K001284STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEMMedtronic Surgical Navigation Technologies · 2000-06-12K990214FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEMSurgical Navigation Technologies, Inc. · 1999-04-22K871247KRONNER UNIVERSAL FRAME EXTERNAL FIXATIONKronner Medical · 1987-05-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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