Device product
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; 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-2087-2017
Product summary
- Event
- Event 76988
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total of all burrs - 608 units
- Official record key
device-enforcement:Z-2087-2017
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 COARSE: GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ; Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;
Distribution pattern: US Nationwide distribution - CA, IL, NY, PA, TN, TX
Derived failure modes
-
Foreign material or chemical contamination
foreign body