Device recall
Z-0919-2025: OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
FDA device recall · Class II · IsoTis OrthoBiologics, Inc.
Key facts
| Recall number (Z-number) | Z-0919-2025 |
|---|---|
| Recall event | 95978 |
| Product | OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. |
| Product code | MQV |
| Recalling firm | IsoTis OrthoBiologics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K242273 |
| FEI number | 3001503333 |
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