Recall Z-1904-2020— Ortho Development Corporation

Name: FDA recall Z-1904-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-30

Class II · Ongoing

Class II FDA medical device recall by Ortho Development Corporation, initiated 2019-05-30. It names one FDA 510(k) clearance: K994370. Product: Tibial Tray Nonporous A Size 4; Model # PN 162-1400-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..

Recalling firm: Ortho Development Corporation
Classification: Class II
Status: Ongoing
Initiated: 2019-05-30
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K994370 — ORTHO DEVELOPMENT BALANCED KNEE SYSTEMOrtho Development Corp.·cleared 2000-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.