The Recall Desk
HighFDA (Devices)·Z-1680-2013·Announced 2013-07-17

ConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect

ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (increased fluid flow to the surgical site) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.

Plain-English summary

ConMed Linvatec is recalling the APEX Arthroscopy Tubing Set, specifically the C7120 (One Connection) and C7122 (Two Connection) models. The recall involves 4,691 units of each model. These devices are intended for joint irrigation and dissection during arthroscopic procedures.

The recall was initiated after the company received complaints that the products contained a scratch or grooved area on the inside diameter of the pressure fitting. This defect may cause the APEX Irrigation (pump) Console to sense a pressure drop, which could result in the device increasing fluid flow to the surgical site.

The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Austria, Belgium, Canada, China, the Czech Republic, Finland, France, Great Britain, Italy, and Japan. Specific lot numbers are listed in the agency's recall record. Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Manufacturer
Linvatec Corp. dba ConMed Linvatec
Category
Medical Device — Surgical Instrument
Hazard
Affected units
4,691

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • C7120 Lot's #: 1301184
  • 1301214
  • 1301254
  • 1301284
  • 1301294
  • 1302014
  • 1302044
  • 1302054
  • 1302064
  • 1302074
  • 13020124
  • 1302134
  • 1302144
  • 1302194
  • 1302204
  • 1302214
  • 1302224
  • 1302254
  • 1302264
  • 1303014

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Linvatec Corp. dba ConMed Linvatec under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Linvatec Corp. dba ConMed Linvatec

See all →

Same hazard · fluid overload

See all →