FDAMay 30, 2019device
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
What to do
FDA enforcement status: Ongoing
Brands named
ortho developmentortho
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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