Ortho Development Corporation recalls Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
- Recall date
- May 30, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1903-2020
- FDA classification
- Class II
- Brand / firm
- Ortho Development Corporation
- Sold / distributed
- US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
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