Recall Z-0532-2015— 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 uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.. Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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 uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.