Drug recall
Exactech Ergo Impactor Handle, Catalog #321-09-05.
FDA recall event 92414 · Class II · Exactech, Inc.
Key facts
| Event ID | 92414 |
|---|---|
| Recall numbers | Z-2050-2023, Z-2051-2023 |
| Recalling firm | Exactech, Inc. |
| Product type | Devices |
| Products | Exactech Ergo Impactor Handle, Catalog #321-09-05., Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| Initiation date | Jun 5, 2023 |
| Report date | Jul 5, 2023 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 1038671 |
At a glance
- 1–9 Products in this recall
- None 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: