Recall Z-2087-2017

Aesculap Implant Systems LLC · initiated March 28, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; GP330R; ELAN 4 2-RING DIAMOND BURR X-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.

Codes / lots: Model numbers COARSE: GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ; Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;

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.

FDA-determined cause: Process control

Action taken

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.

Details

Recall number
Z-2087-2017
Initiated
March 28, 2017
Posted by FDA
April 24, 2017
Terminated
February 6, 2018
Product code
GEY – Motor, Surgical Instrument, Ac-Powered
Quantity
Total of all burrs - 608 units
Distribution
US Nationwide distribution - CA, IL, NY, PA, TN, TX
Recalling firm
Aesculap Implant Systems LLC, Center Valley, PA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2088-2017 Class IIGP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… 03/28/2017Terminated
Z-2089-2017 Class IIGE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR…Diamond particulates may break off the burr and fall into the surgical site. If the particles are not… 03/28/2017Terminated