Class 2 Device Recall JS Series SterilContainer S2

• Date Initiated by Firm: September 08, 2017
• Date Posted: February 15, 2018
• Recall Status: Terminated on April 04, 2019
• Recall Number: Z-0624-2018
• Recall Event ID: 79089
• Product Classification: Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
• Product: JS Series SterilContainer S2 System
• Code Information: JS440 S2 1/1CONT.BOTTON PERFOR.H88MM H202 JS441 S2 1/1 CONT.BOTTOMPERFOR.H1118MM H202 JS442 S2 1/1-CONT.BOTTOM PERFOR.H133MM H202 JS444 S2 1/1 CONT.BOTTOM PEFOR.H185MM H202 JS489 S2 1/1-CONTAINER LID H202 JS740 S2 3/4 CONT.BOTTOM PERFOR.H88MMH202 JS741 S2 3/4 CONT.BOTTOM PERFOR.H118MM H202 JS742 S2 3/4 CONT.BOTTOM PERFOR.H133MM H202 JS789 S2 3/4 CONTAINER LID H202 JS340 S2 1/2 CONT.BOTTOM PERFOR.H88MM H202 JS341 S2 1/2 CONT.BOTTOM PERFOR.H118MM H202 JS342 S2 1/2 CONT.BOTTOM PERFOR.H133MM H202 JS389 S2 1/2 CONTAINER LID H202
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Val Strawn; 800-258-1946
• Manufacturer 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.
• FDA Determined Cause: No Marketing Application
• 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 aesculap_emailorders.bbmus_service@bbraun.com
• Quantity in Commerce: 292 units
• Distribution: Nationally
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.