Drug recall
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802…
FDA recall event 92390 · Class II · New Standard Device Inc
Key facts
| Event ID | 92390 |
|---|---|
| Recall numbers | Z-1824-2023 |
| Recalling firm | New Standard Device Inc |
| Product type | Devices |
| Products | 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The threads on posts stripping out when tensioned during application process. |
| Initiation date | Jul 23, 2019 |
| Report date | Jun 21, 2023 |
| City | San Antonio |
| State | TX |
| Country | United States |
| FEI number | 3015536247 |
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: