FDA-Device2020-05-13Class II
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Ortho Development Corporation
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.
Sold states
US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Affected count
27
Manufactured in
12187 S Business Park Dr, N/A, Draper, UT, United States
Products
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1903-2020Don't want to check this manually?
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