Recall Z-0624-2018— Aesculap Implant Systems LLC

Name: FDA recall Z-0624-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-08

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2017-09-08, terminated 2019-04-04. FDA's recall record names no specific 510(k) clearance for this event. Product: JS Series SterilContainer S2 System. Reason: The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2017-09-08
Terminated: 2019-04-04
Firm location: Center Valley, PA, United States

Product description

JS Series SterilContainer S2 System

Reason for recall

The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

Data sourced from openFDA. This site is unofficial and independent of the FDA.