Z-1582-2014Class II

Disp 9730951 Strl Sphere, 5Pk Insert

Name: Z-1582-2014 Disp 9730951 Strl Sphere, 5Pk Insert
Creator: Medtronic Navigation, Inc.
Published: 2014-04-24
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2014-04-24 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of DISP 9730951 STRL SPHERE, 5PK INSERT on 2014-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1582-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Posted: 2014-05-09
Terminated: 2014-12-29
Recalling firm: Medtronic Navigation, Inc
Product: Disp 9730951 Strl Sphere, 5Pk Insert
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 26,674 total
Distribution: Nationwide Distribution
Product codes and lots: Lot No.: B155300281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1582-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1578-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1579-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1580-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1581-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1582-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1583-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1584-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1585-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1586-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1587-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1588-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1589-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1590-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1591-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1592-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1593-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1594-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1595-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1596-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1597-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1598-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1599-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1600-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1601-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20
Z-1602-2014	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-20

Product code HAW

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)