Device recall
Z-0907-2015: Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device…
FDA device recall · Class II · Spinal Elements, Inc
Key facts
| Recall number (Z-number) | Z-0907-2015 |
|---|---|
| Recall event | 70044 |
| Product | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device. |
| Product code | MAX |
| Recalling firm | Spinal Elements, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2015 |
| 510(k) numbers | K110632 |
| FEI number | 3004893332 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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