JS Series SterilContainer S2 System
Recall
- Recall Number
- Z-0624-2018
- Event Number
- 79089
- Firm
- Aesculap Implant Systems LLC
- FEI Number
- 2916714
- Product Code
- KCT
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- September 8, 2017
- Posted
- February 15, 2018
- Terminated
- April 4, 2019
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
JS Series SterilContainer S2 System
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.
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]
Nationally
292 units