Recall Z-0619-2018 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Aesculap Implant Systems LLC
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC D2.0 ELAN 4 1-RING ROSEN BURR D2.3 ELAN 4 1-RING ROSEN BURR+ D2.3 ELAN 4 1-RING ROS
| Date | Sep 5, 2017 |
| Status | Terminated |
| Reason | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. |
| Root cause | No Marketing Application |
| Action | Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm. |
| Quantity | 10984 |
| Distribution | Distributed to 4 hospitals in the following states: NM, OH, TX, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.