MEDWATCH REPORT FILED ON NOBEL BIOCARE'S
"STERILE" PACKAGING BY IMPLANT DIRECT
READ DR. NIZNICK'S ANALYSIS OF NOBEL BIOCARE'S RESPONSE |
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September 2009 Independent Test Shows Blue Dye In Packaging Containing Nobel Active (PN# 34137) |
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Three Nobel Biocare
implants (2 Nobel Active and 1 Nobel Replace) represented as sterile
on the packaging, failed ASTM D4991-94: “Standard Test Method for
Leakage Testing of Empty Rigid Containers” conducted by a USFDA
certified laboratory, “in accordance with USFDA and
USEPA Regulations.” These test results indicate that Nobel Biocare’s
“sterile” implant packaging may not provide an effective sterility
or microbial barrier and therefore could be considered as failing to
perform as specified and potentially contributing to real or
potential patient harm.
Featured in Implant Direct's September 2009 Newsletter along
with new product announcements
and Free Introductory Offers |
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Narrative Stating
History And Reason
For Medwatch Report |
Attachment 1:
2007 Leak Tests
Nobel Products |
Attachment 2:
2009 Leak Tests
Nobel Products |
Attachment 3:
2009 Leak Tests
Implant Direct Products |
Attachment 4:
Email To Nobel Biocare Executives |
2007- 09 Leak Tests
Implant Direct Products
Maintained Sterile Seal |
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If you are a Nobel Biocare Customer, you may want to ask yourself these questions:
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Have I had any unexplained rejections, failures or infections in the last three years that could be
attributable to a lack of sterility of the implants?
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What liability do I face if I continue to place implants after being made aware of their
potential lack of sterility?
Implant Direct offers a complete line of implants and abutments that are compatible with
Nobel Biocare's Replace Implant System with significant strength, design and cost advantages.
The packaging of our dental implants and healing collars has been confirmed to maintain sterility.
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Post-Script:
October 19, 2009 @ 7:00am EST - Stock Analyst
reports on second study that confirms Nobel's vials
fail leak tests, discusses potential for recall and
advises sale of stocks.
Read Synopsis of Analyst Report
October 19, 2009 @ 12:24pm EST -
Nobel Biocare announces North American
Vice-President "resigns" and COO demoted.
October 23, 2009 - Implant Direct receives Official Notice of Satisfaction from Health Canada.
Implant Direct completed its voluntary recall of implants sold prior to September 2007 with micro-cracks in white caps on September 16, 2009 - only effected exchange of 7 implants from Canadian dental offices.
October 30, 2009 -
Notice to all Canadian Dentists
Implant Direct's Response to Nobel Biocare's continued dissemination of false and misleading information in Canada in an attempt to preserve its Canadian sales and high prices.
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November 24, 2009 -
Notice to all Canadian Dentists
Health Canada clarifies Implant Direct's recall
related to cosmetic micro-cracks on vial cap without
loss of sterility.
NobelActive implants fail dye leak test, indicating
potential loss of sterility.
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December 20, 2009 -
Implant Direct Reports On Failed Dye Leak Test with
NobelActive Implants
February 19, 2010 -
2nd Medwatch Report Filed by Dentist
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April 19, 2010 -
Nobel Biocare's Instructions For Use (IFU)
specifically references, "All implants and various
abutments (see labels) are shipped sterile. Do
not use implants if the packaging has been damaged
or previously opened..". Given the noted
irregularities in Nobel's packaging, can any of
their sterile products be used if one follows
Nobel's own instructions?
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Call 1-888-649-6425 (1-888-NIZNICK) to speak with a Technical Sales representative.
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