Device recall
Z-1436-2021: DirectInject consists of a sterile dual paste system which is calcium phosphate…
FDA device recall · Class II · Stryker Leibinger GmbH & Co. KG
Key facts
| Recall number (Z-number) | Z-1436-2021 |
|---|---|
| Recall event | 87684 |
| Product | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite. |
| Product code | GXP |
| Recalling firm | Stryker Leibinger GmbH & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2022 |
| 510(k) numbers | K143661 |
| FEI number | 3002821504 |
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