INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Code information: Lots: M111057AAP, M111064AAD, M111064AAC, M111063AAJ, M111064AAK, M111064AAL, M111064AAV, M111064AAM, M111064AAW, M111064AAG, M111057AAM, M111063AAD, M111064AAQ, M111064AAO, M111064AAP, M111063AAP, M111064AAB, M111063AAC, M111064AAY, M111057AAD, M111057AAE

Distribution pattern: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.