Recall Z-2100-2021 ยท NDN Cement, Bone, Vertebroplasty
Stryker Spine
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
| Date | May 18, 2021 |
| Status | Terminated |
| Reason | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| Root cause | Storage |
| Action | Urgent Medical Device Recall notification letters dated 5/14/21 were sent to customers. Actions needed NOTE: due to the potential hazards/risks associated with use of product associated with these shipments, please urgently quarantine the in-scope product. 1. Immediately review the Product Recall Notification. Please forward this information to all appropriate personnel within your organization. Maintain awareness of this communication internally until all required actions have been completed within your facility. 2. Immediately check your internal inventory to locate the affected products. |
| Quantity | 559 total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL Orthovita, Inc., Jun 5, 2009 |