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Terminated

Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL, DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042, DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST,, Medtronic, Inc, Minneapolis, Minnesota

FDA Recall Z-0849-2008 · Posted 2008-02-07

Recalling FirmMedtronic Image Guided Neurologics, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2007-10-04
Date Terminated2012-07-13
Product Quantity385

Reason for Recall

Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.

Firm Action

On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone. All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%).

Root Cause

Package design/selection

Distribution Pattern

Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043091NAVIGUS NEXDRIVE, MODEL MI-3000Image-Guided Neurologics, Inc. · 2005-02-07K040334NAVIGUS PASSIVE PROBE, MODEL NP-1000Image-Guided Neurologics, Inc. · 2004-10-04K022100NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010Image-Guided Neurologics, Inc. · 2002-09-25K012366NAVIGUS II TRAJECTORY GUIDEImage-Guided Neurologics, Inc. · 2001-10-01

Official Source

View FDA Recall →

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

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