Device 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.
Z-2088-2017
Product summary
- Event
- Event 76988
- Status
- Terminated
- Classification
- Class II
- Quantity
- total of all burrs 608 units
- Official record key
device-enforcement:Z-2088-2017
Official wording
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.
Code information: Model numbers: GP321R ; GP322R ; GP323R ; GP324R ; GP325R ;
Distribution pattern: US Nationwide distribution - CA, IL, NY, PA, TN, TX
Derived failure modes
-
Foreign material or chemical contamination
foreign body