Device recall
Z-2287-2023: ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide…
FDA device recall · Class II · Materialise N.V.
Key facts
| Recall number (Z-number) | Z-2287-2023 |
|---|---|
| Recall event | 92732 |
| Product | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101 |
| Product code | JEY |
| Recalling firm | Materialise N.V. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K103136 |
| FEI number | 3003998208 |
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