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U.S. Department of Health and Human Services

Class 2 Device Recall ELAN 4 Air System

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  Class 2 Device Recall ELAN 4 Air System see related information
Date Initiated by Firm September 01, 2017
Date Posted February 15, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-0623-2018
Recall Event ID 79092
Product Classification Motor, drill, pneumatic - Product Code HBB
Product The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Code Information ELAN 4 Air System  ST0607 ELAN 4 Air Control Set  ST0608 ELAN 4 Air Neuro Crani Set  ST0609 ELAN 4 Air Spine Set  ST06411 ELAN 4 Air HD Spine Set  ST0614 ELAN 4 Air Micro Saw Set  ST0615 ELAN 4 Air Hand Control Set  ST0638 ELAN 4 Air Large Saw Set 
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946
Manufacturer Reason
for Recall		 The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
FDA Determined
Cause 2		 No Marketing Application
Action On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components: ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set The letter directs customers to take the following actions: 1. Review the Voluntary 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 products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products. 3. Utilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession. If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative). 4. Please contact Customer Service and they will provide you with a Returned Goods number and return label. Customer Service: 1-800-282-9000 aesculap_emailorders.bbmus_service@bbraun.com
Quantity in Commerce 167 Units
Distribution Nationwide Distribution.
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.
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