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Nexframe Stereotactic System Kits, Model Number(s):… recallZ-0849-2008 · Medtronic Image Guided Neurologics, Inc. · initiated Oct 4, 2007

Terminated All recalls posted in February 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Image Guided Neurologics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Package design/selection

What the company is doing

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%).

Recall details

Recall number
Z-0849-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 4, 2007
Posted by the FDA
Feb 7, 2008
Recalling firm
Medtronic Image Guided Neurologics, Inc.
Quantity
385
Product code
HAW
FDA submissions
K012366, K022100, K040334, K043091
Distribution
Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Lot #s: 070380, 061248, 070175, 070375, 070621, 070825, 070634, 6510106A, 046510106A, 46515606, 046520506A, 046521606A, 046523406A,  61262, 70160, 070326, 070171, 60215, 070719, 070378, 070169, 070320, 70543, 070172, 610127, 610133, 70169, 61208, 70313, 51067, 60174, 60215 60578, 046510106C, 70153, 60175, 046510106F, 46534905, 046520506B, 070164, 070633, 070376, 070375, 070538, 070724, 070376, 61264, 61212,  070855, 070854, 070830, 070863, 070726, 070628, 60542, 60573, 60574, 60659, 61262, 70312, 070379, 61216, 70312, 070628, 070726, 61264, 070723 070166, 070629, 070164, 070379, 070856, 60583, 61237, 61238, 606110, 70312, 070159, 70174, 70144, 070160, 70375, 070631, 070825, 070726, 070628, 070863, 61208, 70145, 610134, 70321, 61247, 70315, 70334, 070724 070720, 070602, 070326, 070602, 070631, 070325, 070719, 70123, 70160,  046502607B, 070165, 070826, 046505707B, 60434, 60433, 046510106E

Other devices under the same FDA submission

8 devices cleared under K012366, K022100, K040334, K043091 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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