FDA-Device2013-07-03Class II
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Medtronic Sofamor Danek USA Inc
Hazard
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Sold states
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.
Affected count
22936 units
Manufactured in
1800 Pyramid Place, Memphis, TN, United States
Products
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1589-2013Don't want to check this manually?
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