Drug recall
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards…
FDA recall event 93522 · Class II · Keystone Industries
Key facts
| Event ID | 93522 |
|---|---|
| Recall numbers | Z-0630-2024 |
| Recalling firm | Keystone Industries |
| Product type | Devices |
| Products | KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft… |
| Initiation date | Nov 20, 2023 |
| Report date | Jan 10, 2024 |
| City | Gibbstown |
| State | NJ |
| Country | United States |
| FEI number | 3010002722 |
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: