Device recall
Z-0429-2021: XTANT Medical, ## mm x ## mm x # mm x #,Lordotic/Packaged InTice - C, Sterile…
FDA device recall · Class III · XTANT Medical
Key facts
| Recall number (Z-number) | Z-0429-2021 |
|---|---|
| Recall event | 86602 |
| Product | XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat… |
| Product code | ODP |
| Recalling firm | XTANT Medical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 21, 2021 |
| 510(k) numbers | K173832 |
| FEI number | 3005031160 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database