Drug recall
Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental…
FDA recall event 73460 · Class II · Pelton & Crane / Marus / DCI Equipment / KaVo
Key facts
| Event ID | 73460 |
|---|---|
| Recall numbers | Z-1268-2016 |
| Recalling firm | Pelton & Crane / Marus / DCI Equipment / KaVo |
| Product type | Devices |
| Products | Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation… |
| Initiation date | Mar 8, 2016 |
| Report date | Apr 6, 2016 |
| Termination date | Jun 6, 2016 |
| City | Charlotte |
| State | NC |
| Country | United States |
| FEI number | 1017522 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: