Z-1681-2013Class II

REF C7122QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention...

Name: Z-1681-2013 ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2013-05-30
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2013-05-30 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures on 2013-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1681-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-07-10
Terminated: 2013-09-04
Recalling firm: Linvatec Corporation
Product: ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Product code: HRX Arthroscope
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery or equivalent on 5/30/2013 to all domestic direct consignees. ConMed Linvatec is translating customer notifications letters into the necessary languages and will send International notification letters no later than 6/4/2013.
Quantity in commerce: 4,691 units, total of each
Distribution: 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.
Product codes and lots: C7122 Lots #'s: 1301224, 1301234, 1301244, 1301304, 1301314, 1302114, 1302154, 1302274, 1302284, 1303144, 1303254, 1304044, 1304234, 1304244, and 1305024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1681-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1680-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10
Z-1681-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10

Product code HRX

K961590Class IIApex Universal Irrigation System & Two-Connection Tubing SetLinvatec Corp. / cleared 1996-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)