Recall Z-0879-2017— OrthoPediatrics Corp

Name: FDA recall Z-0879-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-18

Class III · Terminated

Class III FDA medical device recall by OrthoPediatrics Corp, initiated 2016-11-18, terminated 2017-07-27. It names one FDA 510(k) clearance: K083726. Product: OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw. Reason: Labeled as a 48mm Cortical Screw but measuring at 50mm.

Recalling firm: OrthoPediatrics Corp
Classification: Class III
Status: Terminated
Initiated: 2016-11-18
Terminated: 2017-07-27
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K083726 — PEDINAIL INTRAMEDULLARY NAILING SYSTEMOrthoPediatrics Corp.·cleared 2009-03-11

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

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

Reason for recall

Labeled as a 48mm Cortical Screw but measuring at 50mm

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