Aesculap Implant Systems LLC: Medical Device Recall in 2017 - (Recall #: Z-2088-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; 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.

Product Classification:

Class II

Date Initiated: March 28, 2017

Date Posted: May 24, 2017

Recall Number: Z-2088-2017

Event ID: 76988

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.

Status: Terminated

Product Quantity: total of all burrs 608 units

Code Information:

Model numbers: GP321R ; GP322R ; GP323R ; GP324R ; GP325R ;

Distribution Pattern:

US Nationwide distribution - CA, IL, NY, PA, TN, TX

Voluntary or Mandated:

Voluntary: Firm initiated