Recall Z-2087-2017 ยท GEY Motor, Surgical Instrument, Ac-Powered
Aesculap Implant Systems LLC
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 D
| Date | Apr 24, 2017 (initiated Mar 28, 2017) |
| Status | Terminated |
| 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. |
| Root cause | 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 | Total of all burrs - 608 units |
| Distribution | US Nationwide distribution - CA, IL, NY, PA, TN, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.