Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Reported: May 13, 2020 Initiated: May 30, 2019 #Z-1903-2020
Product Description
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-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.
Details
- Recalling Firm
- Ortho Development Corporation
- Units Affected
- 27
- Distribution
- US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
- Location
- Draper, UT
Frequently Asked Questions
What product was recalled? ▼
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.. Recalled by Ortho Development Corporation. Units affected: 27.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1903-2020.
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