FDA Device recall Z-1903-2020
Tibial Tray Nonporous A Size 2
- FDA Device
- Class II
- ongoing
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Tibial Tray Nonporous A Size 2 by Ortho Development, citing 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 resis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1903-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-30 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Development |
| Distribution | CA, FL, OH, PA, TX, UT |
Product
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Reason
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.
Identifiers
| code_info | Lot Number: A200590 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1903-2020%22
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