FDA-Device2016-08-17Class II
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
Integra LifeSciences Corp.
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.
Sold states
US Distribution to the states of : FL, VA, OK, CO, DC and IN.
Affected count
495 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2386-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief