Device recall
Z-1154-2010: Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-1154-2010 |
|---|---|
| Recall event | 48976 |
| Product | Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE" |
| Product code | JEC |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2010 |
| 510(k) numbers | K965029 |
| FEI number | 1000125930 |
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