Recall Z-0316-2022— Wright Medical Technology Inc

Name: FDA recall Z-0316-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-04

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology Inc, initiated 2021-11-04, terminated 2023-01-06. It names one FDA 510(k) clearance: K100886. Product: INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS. Reason: The package contents and package labeling do not match..

Recalling firm: Wright Medical Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2021-11-04
Terminated: 2023-01-06
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K100886 — INBONE II TOTAL ANKLE REPLACEMENTWrightmedicaltechnologyinc·cleared 2010-08-26

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

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

Reason for recall

The package contents and package labeling do not match.

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