Recall Z-2456-2012— Linvatec Corp. dba ConMed Linvatec

Name: FDA recall Z-2456-2012
Creator: U.S. Food and Drug Administration
Published: 2011-05-20

Class II · Terminated

Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2011-05-20, terminated 2012-09-26. It names one FDA 510(k) clearance: K070376. Product: ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source. Reason: Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures..

Recalling firm: Linvatec Corp. dba ConMed Linvatec
Classification: Class II
Status: Terminated
Initiated: 2011-05-20
Terminated: 2012-09-26
Firm location: Largo, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCEConmed Linvatec·cleared 2007-08-20

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

***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source

Reason for recall

Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.

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