Z-2089-2017 Class II Terminated
FDA device recall Z-2089-2017 was initiated by Aesculap Implant Systems LLC on March 28, 2017 and is designated Class II. Reason for recall: 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 part… The recall status is terminated (terminated February 6, 2018). Affected quantity: total amount of burrs - 608.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- March 28, 2017
- Termination Date
- February 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- total amount of burrs - 608
Product Description
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 for Recall
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.
Distribution Pattern
US Nationwide distribution - CA, IL, NY, PA, TN, TX
Code Information
Model numbers: GE426R ; GE426SU ; GE526R ; GE526SU ; GE626R ; GE626SU ;