Ortho Development Corporation recalls Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Mater
Recalled Product
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Hazard / Issue
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.
Issued by
FDA
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