Recall Z-0139-2023— Wright Medical Technology, Inc.

Name: FDA recall Z-0139-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-30

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-09-30. It names one FDA 510(k) clearance: K051023. Product: Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3. Reason: The tibial tray lock detail is oversized (larger than specification)..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-30
Firm location: Memphis, 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

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

Reason for recall

The tibial tray lock detail is oversized (larger than specification).

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