Aesculap Implant Systems LLC: Medical Device Recall in 2018 - (Recall #: Z-0620-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0

Product Classification:

Class II

Date Initiated: September 5, 2017

Date Posted: February 21, 2018

Recall Number: Z-0620-2018

Event ID: 79068

Reason for Recall:

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

Status: Terminated

Product Quantity: 6211

Code Information:

All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R

Distribution Pattern:

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

Voluntary or Mandated:

Voluntary: Firm initiated