Recall Z-0401-2022— Wright Medical Technology, Inc.

Name: FDA recall Z-0401-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-03

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2021-12-03. It names one FDA 510(k) clearance: K141417. Product: Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.. Reason: Incorrect product is contained in the packaging..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-12-03
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K141417 — CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREWWrightmedicaltechnologyinc·cleared 2014-07-09

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 Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

Reason for recall

Incorrect product is contained in the packaging.

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