Recall Z-0535-2015— Instrumed International, Inc.
Class II · Terminated
Class II FDA medical device recall by Instrumed International, Inc., initiated 2014-09-08, terminated 2017-11-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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..
- Recalling firm
- Instrumed International, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-08
- Terminated
- 2017-11-29
- Firm location
- Schaumburg, IL, United States
Product description
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.
Reason for recall
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.