Recall Z-0440-2019 ยท NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Medtronic Sofamor Danek USA Inc
INFUSE Bone Graft X SMALL KIT REF 7510100
| Date | Sep 27, 2018 |
| Status | Terminated |
| Reason | The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS. |
| Root cause | Error in labeling |
| Action | The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product. |
| Quantity | 138 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.