FDAFDA · Food and drugs·Recall number Z-1903-2020
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Published May 13, 2020 · Recall initiated: May 30, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ortho Development Corporation
- Distributor
- US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
- Lot
- Lot Number: A200590
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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