News Release
2005-115
October 26, 2005
For immediate release
Tissue recall in the United States
OTTAWA - Health Canada is advising Canadians of a voluntary recall in the United
States of tissue products used in implants and grafts that were imported into Canada. These tissues
were recovered by Biomedical Tissue Services Limited in the United States from tissue donors who
may not have met Health Canada donor eligibility requirements and who may not have been properly
screened for certain infectious diseases. At this time, tissues that have been implicated include
processed human bone, skin and tendons. The implicated products represent a small percentage of the
tissue supply in Canada.
Health Canada currently estimates that approximately 300 tissue products originating from Biomedical
were imported into Canada. Most of the implicated bone and skin products would have been implanted
or grafted during dental procedures. Other bone products and tendons would have been transplanted
in orthopedic procedures. The risk from use of these products is considered to be low, as tissues
are routinely processed using methods that help to reduce the risk of infectious disease. However,
the actual infectious risk is unknown. To date, no known adverse events from these products have
been reported in Canada or the United States.
Health Canada requirements to determine donor eligibility include important steps to ensure that
donors do not harbor infections that could be transmitted to recipients. These steps include testing
for relevant infectious diseases, physically assessing the donor, and reviewing the donor's medical
history and other factors that may place them at an increased risk of infections that could then
unintentionally be transmitted to recipients through the tissues.
While the risk is believed to be low, Health Canada has taken a number of precautionary measures.
Health Canada sent a letter to the Canadian importers of these tissue products, advising them to
notify all end users who received these products. End users would include, among others, hospitals,
physicians, and dental offices. Health Canada is advising them in turn to notify all patients who
received these tissue products and to provide access to infectious disease testing. The relevant
infectious diseases for which tissue donors are required to be tested in Canada are: HIV-1 and 2
(the viruses that cause AIDS), hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell lymphotropic
virus (HTLV I and II) and syphilis. As well, physicians who still have concerns or questions should
contact the health care facility where the procedure was performed.
In addition, Canada's Public Health Agency of Canada has notified the chief medical officers of Health for the provinces and territories of this issue and has provided them with Health Canada's recommendation to the importers of products originating with Biomedical for patient notification.
Biomedical has sold products to a number of U.S. companies that have exported tissues to Canada.
These companies have all initiated voluntary recalls for all products that were produced using tissues
from Biomedical. Products were imported into Canada from the following companies: Tutogen Medical
Incorporated, which has sold products in Canada to Zimmer Dental of Mississauga, Ontario, and Mentor
Medical Systems Canada Inc. of Oshawa, Ontario; LifeCell Corporation, which has sold products in
Canada to BioHorizons of Markham, Ontario, and Biogenics Inc. of Toronto, Ontario; and Regeneration
Technologies Incorporated, which has sold products in Canada to Laswell of Milton, Ontario, and Medtronic
of Canada Ltd. of Mississauga, Ontario.
Although the risk is believed to be low, Health Canada advises that Canadians who think they might
be affected by this recall should speak with their health care professional.
Health Canada will continue to work with the United States Food and Drug Administration on a priority
basis to obtain more information about the extent of the problem, the risk and those impacted in
order to monitor the recall in Canada. Further public health updates will be issued as needed.
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Media Enquiries:
Nathalie Lalonde
Health Canada
(613) 957-1803
Public Enquiries:
(613) 957-2991
1-866 225-0709
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