Home › Device types › NEK
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA product code NEK · Class 3 · Unknown
6
Registered devices
13,040
Adverse events
8
Recalls
0
510(k) clearances
Devices with this code
INFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.INFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.INFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.INFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.INFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.INFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-09-27 | Medtronic Sofamor Danek USA Inc | The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
| 2013-05-28 | Medtronic Sofamor Danek USA Inc | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. |
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