Recall Z-0534-2015— 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 zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro 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 Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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 zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.