Medical device recalls Moderate risk

Integra LifeSciences Corp. recalls Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Pos…

Recall date
July 20, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2387-2016
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
US Distribution to the states of : FL, VA, OK, CO, DC and IN.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229

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