Z-1904-2020 Class II Ongoing
FDA device recall Z-1904-2020 was initiated by Ortho Development Corporation on May 30, 2019 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- May 30, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
Product Description
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 Pattern
US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Code Information
Lot Number: A204324