Device recall
Z-1515-2014: The Osteo-Clage System consists of stainless steel cable/sleeves and compression…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-1515-2014 |
|---|---|
| Recall event | 67885 |
| Product | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S… |
| Product code | HTY |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2015 |
| 510(k) numbers | K964500 |
| FEI number | 1000125930 |
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