Device recall
Z-1291-2015: Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves…
FDA device recall · Class II · Sybron Dental Specialties
Key facts
| Recall number (Z-number) | Z-1291-2015 |
|---|---|
| Recall event | 70551 |
| Product | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500 |
| Product code | MMP |
| Recalling firm | Sybron Dental Specialties |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2015 |
| 510(k) numbers | K962288 |
| FEI number | 2024312 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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