Date Initiated by Firm | March 28, 2017 |
Date Posted | April 24, 2017 |
Recall Status1 |
Terminated 3 on February 06, 2018 |
Recall Number | Z-2088-2017 |
Recall Event ID |
76988 |
Product Classification |
Motor, surgical instrument, ac-powered - Product Code GEY
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Product | GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3;
GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0;
GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0;
GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0;
GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0;
Product Usage:
The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery. |
Code Information |
Model numbers: GP321R ; GP322R ; GP323R ; GP324R ; GP325R ; |
Recalling Firm/ Manufacturer |
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
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For Additional Information Contact | 800-258-1946 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Process control |
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. |
Quantity in Commerce | total of all burrs 608 units |
Distribution | US Nationwide distribution - CA, IL, NY, PA, TN, TX |
Total Product Life Cycle | TPLC Device Report |
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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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