Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68145

25 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 24, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Navigation, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

25 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 25

BAG 9732315 MOUSE STERILE 15 PK

Z-1578-2014
Recall number
Z-1578-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 5246110712 5316560113

Distribution pattern

Nationwide Distribution

device · product 2 of 25

BIOPSY NEEDLE KIT, 9733068, PASSIVE

Z-1579-2014
Recall number
Z-1579-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 66516213 66501413 66518413 66507713

Distribution pattern

Nationwide Distribution

device · product 3 of 25

BIT 9733516 2.9mm DRILL STERILE

Z-1580-2014
Recall number
Z-1580-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 130204G

Distribution pattern

Nationwide Distribution

device · product 4 of 25

DISP 9730950 STRL SPHERE, 1 PK INSERT

Z-1581-2014
Recall number
Z-1581-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: B135276281

Distribution pattern

Nationwide Distribution

device · product 5 of 25

DISP 9730951 STRL SPHERE, 5PK INSERT

Z-1582-2014
Recall number
Z-1582-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: B155300281

Distribution pattern

Nationwide Distribution

device · product 6 of 25

DRAPE 9732722 TUBE STERILE O-ARM 20PK

Z-1583-2014
Recall number
Z-1583-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: D120065 D121495 D121515 D120175 D122611 D101555

Distribution pattern

Nationwide Distribution

device · product 7 of 25

ENT PRGM 9734636 ADD FUSION NAV AxiEM

Z-1584-2014
Recall number
Z-1584-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 6917614

Distribution pattern

Nationwide Distribution

device · product 8 of 25

INST 9731132 KIT CR REF FRAME DRIVER 5PK

Z-1585-2014
Recall number
Z-1585-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: r683

Distribution pattern

Nationwide Distribution

device · product 9 of 25

INSTRUMENT TRACKER 9733533XOM ENT 1PK

Z-1586-2014
Recall number
Z-1586-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123

Distribution pattern

Nationwide Distribution

device · product 10 of 25

KIT, 9731427, THORACIC TACTILE PROBES

Z-1587-2014
Recall number
Z-1587-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 6688089 6095124 6095129

Distribution pattern

Nationwide Distribution

device · product 11 of 25

MOUSE 9732721 STERILE O-ARM 10PK

Z-1588-2014
Recall number
Z-1588-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 5051140611 5336060213 5162060112 4734921009

Distribution pattern

Nationwide Distribution

device · product 12 of 25

PACK 9731975 TUMOR RESECTION AXIEM CR

Z-1589-2014
Recall number
Z-1589-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 0006922410

Distribution pattern

Nationwide Distribution

device · product 13 of 25

PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

Z-1590-2014
Recall number
Z-1590-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 121130B

Distribution pattern

Nationwide Distribution

device · product 14 of 25

PATIENT TRACKER 9733534XOM ENT 1PK

Z-1591-2014
Recall number
Z-1591-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G

Distribution pattern

Nationwide Distribution

device · product 15 of 25

PIN, 9733235, 100MM, STERILE, PERC REF

Z-1592-2014
Recall number
Z-1592-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 2012110744 2013010347 2012081458

Distribution pattern

Nationwide Distribution

device · product 16 of 25

PIN, 9733236, 150MM, STERILE, PERC REF

Z-1593-2014
Recall number
Z-1593-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 2013041109

Distribution pattern

Nationwide Distribution

device · product 17 of 25

SHUNT KIT 9733605 NON-INVASIVE

Z-1594-2014
Recall number
Z-1594-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A

Distribution pattern

Nationwide Distribution

device · product 18 of 25

SPHERES 8801071 1/TRAY 12PK

Z-1595-2014
Recall number
Z-1595-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 1203122 1205291 1206251 1306081 1309101

Distribution pattern

Nationwide Distribution

device · product 19 of 25

SPHERES 8801075 5/TRAY 12PK

Z-1596-2014
Recall number
Z-1596-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121

Distribution pattern

Nationwide Distribution

device · product 20 of 25

TRAJ GUIDE KIT, 9733065, BIOPSY, EXT

Z-1597-2014
Recall number
Z-1597-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a

Distribution pattern

Nationwide Distribution

device · product 21 of 25

TRAJ GUIDE KIT, 9733066, BIOPSY, INT

Z-1598-2014
Recall number
Z-1598-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 0066233912C 0066201113B 0066212611B 0066233912C 066209012 066209012

Distribution pattern

Nationwide Distribution

device · product 22 of 25

TUMOR RES. PACK 9733553 AxiEM S.M.

Z-1599-2014
Recall number
Z-1599-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 6402019 6402024

Distribution pattern

Nationwide Distribution

device · product 23 of 25

TUMOR RESECTION KIT 9733607 NON-INVASIVE

Z-1600-2014
Recall number
Z-1600-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C

Distribution pattern

Nationwide Distribution

device · product 24 of 25

TUMOR RESECTION KIT 9733608 SKULL MOUNT

Z-1601-2014
Recall number
Z-1601-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 120725D 130404B

Distribution pattern

Nationwide Distribution

device · product 25 of 25

UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

Z-1602-2014
Recall number
Z-1602-2014
Initiated
April 24, 2014
Classification
Class II
Status
Terminated
Quantity
26,674 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot No.: 6148186

Distribution pattern

Nationwide Distribution

Field note

Send feedback

We'll only use this to respond to your feedback.