Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennes

Recalled July 3, 2013 · FDA recall Z-1593-2013 · Medtronic Sofamor Danek USA

Hazard

Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. · FDA Class II

Units

1319 units

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Medtronic Sofamor Danek USA Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →