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FDA recalling certain allograft transplantation tissues

Questions over donor-eligibility documentation mean some tissue recipients may be at risk for infections.

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Five tissue processors are working with the FDA in a voluntarily recall of human tissue transplantation products derived from tissue originally recovered by Biomedical Tissue Services Ltd. of Ft. Lee, N.J.

According to the FDA, Biomedical Tissue Services (BTS) recovered human bone, skin and tendons from donors who may not have met FDA donor-eligibility requirements. The donors also may not have been properly screened for certain infectious diseases.

LifeCell Corp. of Branchburg, N.J., initiated the first recall on September 30 after internal quality processes raised questions about donor documentation it received from BTS. The company then notified the FDA and all relevant hospitals and medical professionals of its action.

The LifeCell recall involves certain of the company’s AlloDerm, Repliform and GraftJacket products.

Lost Mountain Tissue Bank of Kennesaw, Ga., followed LifeCell and on October 10 began withdrawing all of its tissue products with identification numbers beginning with the letters “GL� or �T.� Lost Mountain was soon followed by The Blood and Tissue Center of Central Texas in Austin, Texas, by Tutogen Medical Inc. of Alachua, Fla., and by Regeneration Technologies Inc. of Alachua, Fla.

All companies cited concerns over documentation of donor eligibility, screening and medical history for the recalls.

Although the involved allograft products represent only a small percentage of the overall U.S. tissue supply, some tissue may have been implanted into patients from early 2004 to September 2005, according to an FDA news release.

FDA officials noted in the release that no tissue-related adverse reactions have been reported at this time. However, because of the potential lack of proper donor screening, some recipients may be at increased risk of certain infections.

Both the FDA and the Centers for Disease Control and Prevention (CDC) believe the infection risks are low due to the use of routine processing methods, which help reduce disease transmission risk. However, the actual risk is unknown.

The FDA and CDC have recommended that physicians who may have used tissues involved in the recalls inform their patients of the situation. The two agencies also recommend physicians offer patients access to appropriate infectious disease testing, particularly for the following diseases:

1. HIV-1 and HIV-2;
2. hepatitis B virus;
3. hepatitis C virus; and
4. syphilis.

The FDA has further requested that patients and physicians report any potential tissue-related infectious diseases to the tissue-processing firms, which should then notify the FDA. Patients and physicians can also notify the FDA directly using the agency’s MedWatch reporting program at www.fda.gov/medwatch.

Editors Note: Click here to read more in depth coverage of this recall, published in the December 2005 issue of Orthopedics Today.