Drug recall
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The…
FDA recall event 69050 · Class II · OrthoPediatrics Corp
Key facts
| Event ID | 69050 |
|---|---|
| Recall numbers | Z-2560-2014 |
| Recalling firm | OrthoPediatrics Corp |
| Product type | Devices |
| Products | ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. |
| Initiation date | Jul 25, 2014 |
| Report date | Sep 10, 2014 |
| Termination date | May 19, 2015 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 3006460162 |
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: