Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB

FDA device recall Z-0849-2008 · posted 2008-02-07 · Terminated

Recall details

Recalling firm

Medtronic Image Guided Neurologics, Inc.

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.

Action taken

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

Status

Terminated

Product code

HAW

Quantity affected

385

Distribution

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

Date initiated

2007-10-04

Date posted

2008-02-07

Date terminated

2012-07-13

Location

Melbourne, FL

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