Z-0624-2018Class II

JS Series SterilContainer S2 System

Name: Z-0624-2018 JS Series SterilContainer S2 System
Creator: Aesculap Implant Systems LLC
Published: 2017-09-08
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-09-08 / Terminated / root cause: sterility

FDA source

Aesculap Implant Systems LLC began a recall of JS Series SterilContainer S2 System on 2017-09-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0624-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-08
Posted: 2018-02-15
Terminated: 2019-04-04
Recalling firm: Aesculap Inc
Product: JS Series SterilContainer S2 System
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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.
Root cause tag: sterility
FDA root 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 [email protected]
Quantity in commerce: 292 units
Distribution: Nationally
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0624-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0624-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code KCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)