FDAFDA · Food and drugs·Recall number Z-2386-2016
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
Published August 17, 2016 · Recall initiated: July 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- US Distribution to the states of : FL, VA, OK, CO, DC and IN.
- Lot
- Lot # GT0420 and GT0419
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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