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Musculoskeletal Allograft Risks and Recalls in the United States

Perspectives on Modern Orthopaedics articles provide an objective appraisal of new or controversial techniques or areas of investigation in orthopaedic surgery.

Dr. Mroz is Staff Spine Surgeon, Neuroscience Institute, Center for Spine Health, The Cleveland Clinic, Cleveland, OH. Dr. Joyce is Staff Surgeon, Department of Orthopaedic Surgery, and Medical Director, Cleveland Clinic Musculoskeletal Tissue Storage Facility, The Cleveland Clinic. Dr. Steinmetz is Staff Spine Surgeon, Neuroscience Institute, Center for Spine Health, The Cleveland Clinic. Dr. Lieberman is Chairman, Medical Interventional and Surgical Spine Center, and Professor of Surgery and Staff Orthopaedic and Spinal Surgeon, The Cleveland Clinic Florida, Weston, FL. Dr. Wang is Chief, Orthopaedic Spine Service, and Associate Professor of Orthopaedics, Neurosurgery and Biomedical Engineering, UCLA Comprehensive Spine Center, Santa Monica, CA.

Reprint requests: Dr. Mroz, Neuroscience Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, S-80, Cleveland, OH 44195.

Dr. Mroz or a member of his immediate family has received research or institutional support from DePuy, Abbott, Stryker, Zimmer, and Synthes. Dr. Joyce or a member of his immediate family is a consultant for the Musculoskeletal Transplant Foundation. Dr. Steinmetz or a member of his immediate family has received miscellaneous nonincome support from Stryker Spine and Kyphon. Dr. Lieberman or a member of his immediate family has received research or institutional support from Stryker, DePuy, Orthovita, Medtronic, Mazor, Merlot, TranS1, Kyphon, Axiomed, and Crosstrees; has received royalties from Merlot, Mazor, TranS1, Crosstrees, Axiomed, Stryker, and DePuy; has stock or stock options held in Merlot, Axiomed, TranS1, and Crosstrees; and is a consultant to or employee of Mazor, Merlot, TranS1, Kyphon, Axiomed, and Crosstrees. Dr. Wang or a member of his immediate family is a consultant or employee of Medtronics, DePuy, Synthes, Stryker, Zimmer, BioMet, and Sea Spine.

There have been several improvements to the US tissue banking industry over the past decade. Tissue banks had limited active government regulation until 1993, at which time the US Food and Drug Administration began regulatory oversight because of reports of disease transmission from allograft tissues. Reports in recent years of disease transmission associated with the use of allografts have further raised concerns about the safety of such implants. A retrospective review of allograft recall data was performed to analyze allograft recall by tissue type, reason, and year during the period from January 1994 to June 30, 2007. During the study period, more than 96.5% of all allograft tissues recalled were musculoskeletal. The reasons underlying recent musculoskeletal tissue recalls include insufficient or improper donor evaluation, contamination, recipient infection, and positive serologic tests. Infectious disease transmission following allograft implantation may occur if potential donors are not adequately evaluated or screened serologically during the prerecovery phase and if the implant is not sterilized before implantation.