Device recall
Z-1334-2023: Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b)…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-1334-2023 |
|---|---|
| Recall event | 91697 |
| Product | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF… |
| Product code | MBP |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000477302 |
At a glance
- None Linked 510(k)s
- 10–99 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