Recall Z-1291-2022— Wright Medical Technology, Inc.

Name: FDA recall Z-1291-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-02

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-06-02. It names one FDA 510(k) clearance: K140749. Product: Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.. Reason: The instrument is incorrectly color coded..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-02
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K140749 — INFINITY TOTAL ANKLE SYSTEMWrightmedicaltechnologyinc·cleared 2014-04-25

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 INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

Reason for recall

The instrument is incorrectly color coded.

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