Draper, UT, United States
Ortho Development Corporation recalls
1 recall recorded since 2018, most recently on 30 May 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 May 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1903-2020, Z-1904-2020
- Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
- Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.