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Ortho Development Corporation recalls Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Recalled May 13, 2020 · FDA recall Z-1903-2020 · Ortho Development
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. · FDA Class II
Units
27
Sold at
US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Description
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.
Product
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Manufacturer(s)
Ortho Development Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →