Events

Recall of GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217.

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
    76988
  • Event Risk Class
    Unclassified Correction
  • Event Initiated Date
    2017-03-28
  • Event Status
    Firm initiated action, Not yet classified 1
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154778
  • 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
    Motor, Surgical Instrument, Ac-Powered - Product Code GEY
  • Reason
    Diamond particulates may break off the burr and fall into the surgical site. if the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. these particulates could also lead to mechanically induced soft tissue damage.
  • Action
    On April 7, 2017 8 Hospitals, 3 distributors and 11 sales reps were sent an Urgent Medical Device Recall Notification letter. Letters were sent UPS overnight. Customers were asked to immediately discontinue use and return the product to Aesculap, Inc.

Device

GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2....
  • Model / Serial
    Model numbers COARSE:  GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ;  Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, IL, NY, PA, TN, TX
  • Product Description
    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;
  • Manufacturer
    Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217

Manufacturer

Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217