FDA-Device2013-07-17Class II
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Linvatec Corp. dba ConMed Linvatec
Hazard
Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
Sold states
Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.
Affected count
4,691 Units total of each
Manufactured in
11311 Concept Blvd, N/A, Largo, FL, United States
Products
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1680-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief