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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-0619-2018
Recall Event ID 79068
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6
ELAN 4 1-RING ROSEN BURR+ D0.8
ELAN 4 1-RING ROSEN BURR D1.0
ELAN 4 1-RING ROSEN BURR TC D1.0
ELAN 4 1-RING ROSENBURR+ D1.0
ELAN 4 1-RING ROSEN BURR D1.4
ELAN 4 1-RING ROSENBURR+ D1.4
ELAN 4 1-RING ROSEN BURR D1.8
ELAN 4 1-RING ROSEN BURR+ D1.8
ELAN 4 1-RING ROSEN BURR TC D2.0
ELAN 4 1-RING ROSEN BURR D2.3
ELAN 4 1-RING ROSEN BURR+ D2.3
ELAN 4 1-RING ROSEN BURR D2.7
ELAN 4 1-RING ROSEN BURR+ D2.7
ELAN 4 1-RING ROSEN BURR D3.0
ELAN 4 1-RING ROSEN BURR TC D3.0
ELAN 4 1-RING ROSEN BURR D3.5
Code Information All lots, Model Number: GP111R GP112R GP113R GP113TC GP114R GP115R GP116R GP117R GP118R GP119TC GP120R GP121R GP122R GP123R GP124R GP124TC GP125R GP126R GP126TC GP127R GP128R GP128TC GP129R GP129TC GP133R GP134R GP135R GP136R GP141R GP142R GP143R GP144R GP145R GP146R GP147R GP148R GP149R GP150R GP151R GP152R GP153R GP154R GP155R GP156R GP157R GP158R GP161R GP162R GP163R GP164R GP165R GP166R GP167R GP168R GP169R GP170R GP173R GP174R GP175R GP176R GP177R GP184R GP185R GP186R GP187R GP193R GP194R GP195R GP196R GP224R GP225R GP226R GP228R GP229R GP230R GP232R GP233R GP234R GP235R GP236R GP238R GP240R GP241R GP242R GP243R GP301R GP301TC GP302R GP302TC GP303R GP304R GP304TC GP305R GP306R GP306TC GP307R GP307TC GP308R GP308TC GP309R GP309TC GP311R GP312R GP313R GP314R GP315R GP316R GP317R GP321R GP322R GP323R GP324R GP325R GP328R GP329R GP330R GP335R GP336R GP337R GP338R GP339R GP350R GP355R GP356R GP357R GP358R GP374R GP375R GP376R GP378R GP379R GP380R GP382R GP384R GP385R GP386R GP388R GP389R GP391R GP392R GP393R GP395TC GP397R US792R US793R US794R US771R US772R US773R US774R US775R US776R US777R US783TC US785TC US787R US788TC US790TC US800R US801R US807R US852TC US853R US861R US825R US831R 
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 10984
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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