FDAJune 21, 2016device

Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

What to do

FDA enforcement status: Terminated

Brands named

microport orthopedicsmicroport

UPCs

08991148910010103054910

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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