Device recall
Z-0951-2023: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8)…
FDA device recall · Class II · Depuy Ireland UC
Key facts
| Recall number (Z-number) | Z-0951-2023 |
|---|---|
| Recall event | 91261 |
| Product | BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20) |
| Product code | LZN |
| Recalling firm | Depuy Ireland UC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K943727 |
| FEI number | 3015516266 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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