Recall Z-1924-2020— Wright Medical Technology Inc

Name: FDA recall Z-1924-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-09

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology Inc, initiated 2020-04-09, terminated 2020-11-02. It names one FDA 510(k) clearance: K051023. Product: WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.. Reason: One lot of INBONE Tibial Trays is missing the plasma coating..

Recalling firm: Wright Medical Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2020-04-09
Terminated: 2020-11-02
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K051023 — TOPEZ TOTAL ANKLE REPLACEMENTTopez Orthopedics, Inc.·cleared 2005-11-15

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

WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Reason for recall

One lot of INBONE Tibial Trays is missing the plasma coating.

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