Recall Z-1900-2020 ยท NDN Cement, Bone, Vertebroplasty
Howmedica Osteonics Corp.
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
| Date | Apr 1, 2020 |
| Status | Terminated |
| Reason | Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism. |
| Root cause | Storage |
| Action | On April 1, 2020, the firm distributed Urgent Medical Device Recall letters to all affected customers. Customers were informed that the product had been transported outside of the required refrigerated temperature conditions, which protect the active material components from degradation, and help maintain optimal product set time as well as optimal mechanical properties. Customers were instructed to do the following: NOTE: due to the potential hazards/risks associated with future use of product associated with these shipments, please urgently quarantine the in-scope product. 1. Immediately |
| Quantity | 115 |
| Distribution | US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL Orthovita, Inc., Jun 5, 2009 |