Recall Z-1593-2013— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-1593-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2013-05-28, terminated 2014-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, 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..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Terminated: 2014-05-13
Firm location: Memphis, TN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.