FDA recall Z-1904-2020

Product

Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.

Reason for recall

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.

Distribution

US: CA, FL, OH, PA, TX, and UT. OUS: Japan.

Key facts

Status

Ongoing

Initiation date

2019-05-30

Report date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Draper, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1904-2020