Recall Z-0111-2015— Signal Medical Corporation

Name: FDA recall Z-0111-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-30

Class II · Terminated

Class II FDA medical device recall by Signal Medical Corporation, initiated 2014-09-30, terminated 2016-03-14. It names one FDA 510(k) clearance: K080199. Product: Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).. Reason: Packaging of a device was compromised.

Recalling firm: Signal Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-09-30
Terminated: 2016-03-14
Firm location: Marysville, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K080199 — SYMMETRIC TOTAL KNEE SYSTEMSignal Medical Corporation·cleared 2008-07-03

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

Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).

Reason for recall

Packaging of a device was compromised

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