Recall Z-1486-2015— Wright Medical Technology, Inc.

Name: FDA recall Z-1486-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-06

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2015-03-06, terminated 2018-08-05. It names one FDA 510(k) clearance: K132594. Product: CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.. Reason: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-06
Terminated: 2018-08-05
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K132594 — CROSSCHECK PLATING SYSTEMSolana Surgical, LLC·cleared 2013-12-13

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

CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.

Reason for recall

The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

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