FDA-Device2016-08-17Class II
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
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
111 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2387-2016Don't want to check this manually?
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