Recall Z-2089-2017 ยท GEY Motor, Surgical Instrument, Ac-Powered
Aesculap Implant Systems LLC
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high
| 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 amount of burrs - 608 |
| 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.