Recall Z-0618-2018 ยท MQV Filler, Bone Void, Calcium Compound
Synthes USA
Norian Drillable Inject
| Date | Aug 10, 2017 |
| Status | Terminated |
| Reason | The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit. |
| Root cause | Process control |
| Action | On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited. |
| Quantity | 5 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073303 | NORIAN DRILLABLE Synthes (Usa), Jul 2, 2008 |