FDAJuly 21, 2020device
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
UPCs
10886982166913
Recall history
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