Drug recall
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive…
FDA recall event 54725 · Class II · Orthohelix Surgical Designs Inc
Key facts
| Event ID | 54725 |
|---|---|
| Recall numbers | Z-0026-2013, Z-0027-2013 |
| Recalling firm | Orthohelix Surgical Designs Inc |
| Product type | Devices |
| Products | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and…, OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The tips of the drivers are breaking while being used to drive the screws into patients. |
| Initiation date | Jan 29, 2010 |
| Report date | Oct 17, 2012 |
| Termination date | Feb 20, 2013 |
| City | Medina |
| State | OH |
| Country | United States |
| FEI number | 3005039508 |
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: