Device recall
Z-1839-2014: Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1)…
FDA device recall · Class II · ConMed Corporation
Key facts
| Recall number (Z-number) | Z-1839-2014 |
|---|---|
| Recall event | 67610 |
| Product | Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001… |
| Product code | GEI |
| Recalling firm | ConMed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2017 |
| 510(k) numbers | K101534 |
| FEI number | 3001451571 |
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