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U.S. Department of Health and Human Services

Class 2 Device Recall ELAN 4

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  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-0621-2018
Recall Event ID 79068
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5
ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5
ELAN 4 1-RING NEURO CUTTER SOFT D3.0
ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0
ELAN 4 1-RING NEURO CUTTER D2.0
ELAN 4 1-RING NEURO CUTTER D2.5
ELAN 4 1-RING NEURO CUTTER D3.0
ELAN 4 1-RING NEURO CUTTER TC D3.0
ELAN 4 1-RING NEURO CUTTER DIAM.D1.5
ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5
ELAN 4 1-RING NEURO CUTTER DIAM.D2.0
ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0
ELAN 4 1-RING NEURO CUTTER DIAM.D2.5
ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5
ELAN 4 1-RING NEURO CUTTER DIAM.D3.0
ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0
ELAN 4 1-RING NEURO CUTTER DIAM.D4.0
ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0
ELAN 4 2-RING CRANIOTOME CUTTER PAED
ELAN 4 2-RING CRANIOTOME CUTTER STANDARD
ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED
ELAN 4 2-RING CRANIOTOME CUTTER STANDARD
ELAN 4 2-RING CRANIOTOME CUTTER LONG
ELAN 4 2-RING NEURO CUTTER SOFT D2,0
ELAN 4 2-RING NEURO CUTTER SOFT D2,5
ELAN 4 2-RING NEURO CUTTER SOFT D3,0
ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0
ELAN 4 2-RING NEURO CUTTER SOFT D3,0
ELAN 4 2-RING NEURO CUTTER TC D3,0
ELAN 4 2-RING NEURO CUTTER DIAM. D3,0
ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0
ELAN 4 2-RING DIAMOND DISC
ELAN 4 2-RING SIDE CUTTER TC D3,0
SAW BLADE S sagittal 11/13/0,3
SAW BLADE S sagittal 15/5/0,3
SAW BLADE S sagittal 20/5/0,3
SAW BLADE S sagittal 20/10/0,3
SAW BLADE S sagittal 20/15/0,3
SAW BLADE S sagittal 25/5/0,3
SAW BLADE S sagittal 25/12/0,3
RECIPROCATING SAW BLADE MICRO 13/0.3
RECIPROCATING SAW BLADE MICRO 20/0.3
RECIPROCATING SAW BLADE MICRO 13/0.3
RECIPROCATING SAW BLADE MICRO 20/0.3
ELAN 4 1-RING NEURO CUTTER D1.5+
ELAN 4 1-RING NEURO CUTTER D2.0+
ELAN 4 1-RING NEURO CUTTER D2.5+
ELAN 4 1-RING NEURO CUTTER D3.0+
ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0
ELAN 4 1-RING NEURO PRECISE D1.5
ELAN 4 1-RING NEURO PRECISE D2.0
ELAN 4 1-RING NEURO PRECISE D2.5
ELAN 4 1-RING NEURO PRECISE D3.0
ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8
ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5
Code Information All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R 
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.
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