Recall Z-2089-2017— Aesculap Implant Systems LLC

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2017-03-28, terminated 2018-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.. 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..

Recalling firm

Aesculap Implant Systems LLC

Classification

Class II

Status

Terminated

Initiated

2017-03-28

Terminated

2018-02-06

Firm location

Center Valley, PA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.