# FDA recall Z-1904-2020

> **Ortho Development Corporation** · Class II · device recall initiated 2019-05-30.

## Product

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

US: CA, FL, OH, PA, TX, and UT.  OUS: Japan.

## Key facts

- **Recall number:** Z-1904-2020
- **Recalling firm:** Ortho Development Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-05-30
- **Report date:** 2020-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Draper, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1904-2020

## Citation

> AI Analytics. FDA recall Z-1904-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1904-2020. Source: US FDA. Licensed CC0.

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