Events

Recall of ELAN 4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap Implant Systems LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79068
  • Event Risk Class
    Class 2
  • Event Number
    Z-0619-2018
  • Event Initiated Date
    2017-09-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161269
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Reason
    Elan 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
  • 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.

Device

ELAN 4
  • Model / Serial
    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
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 4 hospitals in the following states: NM, OH, TX, WV
  • Product Description
    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
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Manufacturer Address
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA