Home / Recalls / Medical Devices
Instrumed International, Inc. recalls A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of t
Recalled December 17, 2014 · FDA recall Z-0535-2015 · Instrumed International
Hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. · FDA Class II
Units
11 trocars
Sold at
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Description
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Product
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Manufacturer(s)
Instrumed International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →