Purpose of study: This poster provides an analysis of data collected and disseminated by the US Food and Drug Administration (FDA) concerning recalls of musculoskeletal tissue allografts and includes a discussion of the implications for patient safety.Methods used: The FDA collects and publishes information concerning recalls of regulated products, including musculoskeletal tissue allografts, on a weekly basis. For each recall, data are provided concerning the specific products involved in the recall, the “recalling” firm or manufacturer, the reasons for the recall, the volume of products and the geographic distribution of the recalled products. All FDA reports from 1994 through 2001 were reviewed to identify those recalls that involved musculoskeletal tissue. The reasons for recall, numbers of grafts recalled, trends over time and implications for patient safety were analyzed.of findings: From 1994 through 2001, a total of 15,338 musculoskeletal tissue allografts were recalled in the United States. The most common reasons for recall include “improper donor evaluation” (10,929 grafts; 71.3%), and/or presence of positive serology results (3,140 grafts; 20.5%), results (976 grafts; 6.4%). Analysis of trends over time show that improper donor screening and testing, mishandling of positive serology results and other human errors continue to occur quite commonly (to date, 1,235 musculoskeletal tissue grafts have been reported as recalled in 2001).Relationship between findings and existing knowledge: Case reports document that transmission of disease to allograft recipients has occurred because of graft contamination with each of the following pathogens: bacteria, fungi, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and human T-lymphotropic virus. Although it remains uncertain how many of the recalled allografts had already been implanted in recipients at the time of the recalls, data from the current analysis indicate that many recipients are being placed at risk each year because of human errors in screening, testing and processing donor musculoskeletal tissue.Overall significance of findings: Recent reports from the Centers for Disease Control emphasize that disease transmission to recipients through use of contaminated allografts represents an ongoing and serious public health problem. Some of the risk is the result of the inherent limitations of current methods of donor screening and testing (eg, false-negative test results) as well as lack of validation studies for most methods of processing musculoskeletal tissue to verify whether the allografts are not contaminated. Unfortunately, data from the current study document that human errors in screening and testing donors of musculoskeletal tissue represent an additional important source of risk for recipient exposure to various serious diseases. Adoption of quality improvement initiatives by the tissue bank industry might be useful in reducing the number of human errors. Also, there is a great need for validated methods of sterilizing allografts to prevent transmission of disease when donor screening and testing fail.Disclosures: No disclosures.Conflict of interest: Randal Mills, PhD, stockholder; Randal Mills, PhD, other support; Dayna Buskirk, employee of Regenerations Technologies, Inc.