Device recall
Z-1060-2012: Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System")…
FDA device recall · Class II · Ascension Orthopedics, Inc
Key facts
| Recall number (Z-number) | Z-1060-2012 |
|---|---|
| Recall event | 60855 |
| Product | Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is… |
| Product code | KXE |
| Recalling firm | Ascension Orthopedics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 14, 2013 |
| FEI number | 3002788818 |
At a glance
- None 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