Drug recall
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System…
FDA recall event 74757 · Class II · Integra LifeSciences Corp.
Key facts
| Event ID | 74757 |
|---|---|
| Recall numbers | Z-2386-2016, Z-2387-2016 |
| Recalling firm | Integra LifeSciences Corp. |
| Product type | Devices |
| Products | Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229, Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. |
| Initiation date | Jul 20, 2016 |
| Report date | Aug 17, 2016 |
| Termination date | Dec 16, 2016 |
| 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: