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Recall Observatory FDA recall evidence

Device product

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

Z-1681-2013

May 30, 2013

Class II

Product summary

Firm
Linvatec Corp. dba ConMed Linvatec
Event
Event 65320
Status
Terminated
Classification
Class II
Quantity
4,691 units, total of each
Official record key
device-enforcement:Z-1681-2013

Official wording

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.

Code information: C7122 Lots #'s: 1301224, 1301234, 1301244, 1301304, 1301314, 1302114, 1302154, 1302274, 1302284, 1303144, 1303254, 1304044, 1304234, 1304244, and 1305024

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.