JS Series SterilContainer S2 System

FDA device recall Z-0624-2018 · posted 2018-02-15 · Terminated

Recall details

Recalling firm

Aesculap Implant Systems LLC

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.

Action taken

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

Root cause

No Marketing Application

Status

Terminated

Product code

KCT

Quantity affected

292 units

Distribution

Nationally

Date initiated

2017-09-08

Date posted

2018-02-15

Date terminated

2019-04-04

Location

Center Valley, PA