Device recall
Z-0234-2020: SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm…
FDA device recall · Class II · Pajunk GmbH
Key facts
| Recall number (Z-number) | Z-0234-2020 |
|---|---|
| Recall event | 83714 |
| Product | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G… |
| Product code | BSP |
| Recalling firm | Pajunk GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K911260 |
| FEI number | 3002807847 |
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