Device recall
Z-0578-2014: ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only…
FDA device recall · Class II · Materialise USA LLC
Key facts
| Recall number (Z-number) | Z-0578-2014 |
|---|---|
| Recall event | 66935 |
| Product | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. . |
| Recalling firm | Materialise USA LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2014 |
| FEI number | 3005718816 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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