Drug recall
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model…
FDA recall event 65503 · Class II · Integra LifeSciences Corp.
Key facts
| Event ID | 65503 |
|---|---|
| Recall numbers | Z-1685-2013 |
| Recalling firm | Integra LifeSciences Corp. |
| Product type | Devices |
| Products | Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. |
| Initiation date | Feb 1, 2013 |
| Report date | Jul 17, 2013 |
| Termination date | Jul 25, 2013 |
| City | Plainsboro |
| State | NJ |
| Country | United States |
| FEI number | 3003418325 |
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: