INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Reported: July 3, 2013 Initiated: May 28, 2013 #Z-1595-2013
Product Description
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, 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.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 2090 units
- Distribution
- 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.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 2090 units.
Why was this product recalled? ▼
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2013. Severity: Moderate. Recall number: Z-1595-2013.
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