Device recall
Z-1177-2012: Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option…
FDA device recall · Class II · Pelton & Crane Company
Key facts
| Recall number (Z-number) | Z-1177-2012 |
|---|---|
| Recall event | 61262 |
| Product | Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 Product Usage: The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe… |
| Product code | EIA |
| Recalling firm | Pelton & Crane Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2012 |
| 510(k) numbers | K946187 |
| FEI number | 1017522 |
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