Recall Z-1681-2013— Linvatec Corp. dba ConMed Linvatec

Name: FDA recall Z-1681-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-30

Class II · Terminated

Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2013-05-30, terminated 2013-09-04. It names one FDA 510(k) clearance: K961590. Product: ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.. Reason: 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..

Recalling firm: Linvatec Corp. dba ConMed Linvatec
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Terminated: 2013-09-04
Firm location: Largo, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K961590 — APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SETLinvatec Corp.·cleared 1996-10-08

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 C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.

Reason for recall

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.

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