Recall Z-2447-2018— NewDeal SA

Name: FDA recall Z-2447-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-22

Class II · Terminated

Class II FDA medical device recall by NewDeal SA, initiated 2018-05-22, terminated 2019-11-04. It names one FDA 510(k) clearance: K093914. Product: TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S. Reason: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal..

Recalling firm: NewDeal SA
Classification: Class II
Status: Terminated
Initiated: 2018-05-22
Terminated: 2019-11-04
Firm location: St Priest, France

510(k) clearances named in this recall

1 on FDA's record

K093914 — NEWDEAL COMPRESSION PLATESNewdeal Sas·cleared 2011-04-14

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

TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

Reason for recall

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

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