Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1903-2020 — Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.

U.S. FDA — Device Enforcement · United States · 2019-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1903-2020
Date of alert
2019-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho Development Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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