JS Series SterilContainer S2 System
FDA Recall Z-0624-2018 · Posted 2018-02-15
Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeKCT
Date Initiated2017-09-08
Date Terminated2019-04-04
Product Quantity292 units
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.
Firm Action
On August 24, 2017 a Medical Device Recall(Reference 2916714-08/24/2017-010R) was issued requesting that all customers take the following steps: 1.Review the Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use.
2. Determine your current inventory of affected containers within your facility. Immediately quarantine the affected products. A sales representative will come to your facility and remove your affected product and immediately return it to Aesculap Inc. They will assist you with ordering an appropriate replacement container. Do not destroy any affected products.
3. Please contact Customer Service and they will provide you a Returned Good number and a return label.
Customer Service:
Phone: 1-800-282-9000
[email protected]
Root Cause
No Marketing Application
Distribution Pattern
Nationally
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.