Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ELAN 4

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ELAN 4 see related information
Date Initiated by Firm September 05, 2017
Create Date February 15, 2018
Recall Status1 Terminated 3 on September 20, 2019
Recall Number Z-0620-2018
Recall Event ID 79068
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5
ELAN 4 1-RING TWIST DRILL D2.0
ELAN 4 2-RING TWIST DRILL D1,0/4,0MM
ELAN 4 2-RING TWIST DRILL D1,1/4,0MM
ELAN 4 2-RING TWIST DRILL D1,2/4,0MM
ELAN 4 2-RING TWIST DRILL D1,5/4,0MM
ELAN 4 2-RING TWIST DRILL D1,5
ELAN 4 2-RING TWIST DRILL D2,0
ELAN 4 2-RING WIRE PASS DRILL D1.0
ELAN 4 2-RING WIRE PASS DRILL D1.5
ELAN 4 2-RING WIRE PASS DRILL D2.0
ELAN 4 2-RING WIRE PASS DRILL D1.0
ELAN 4 2-RING WIRE PASS DRILL D1.5
ELAN 4 2-RING WIRE PASS DRILL D2.0
Code Information All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R 
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Val Strawn
610-984-9414 Ext. 5414
Manufacturer Reason
for Recall		 ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
FDA Determined
Cause 2		 No Marketing Application
Action Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.
Quantity in Commerce 6211
Distribution Distributed to 4 hospitals in the following states: NM, OH, TX, WV
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.
-
-