Z-0620-2018 Class II Terminated
FDA device recall Z-0620-2018 was initiated by Aesculap Implant Systems LLC on September 5, 2017 and is designated Class II. Reason for recall: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. The recall status is terminated (terminated September 20, 2019). Affected quantity: 6211.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- September 5, 2017
- Termination Date
- September 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6211
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
Reason for Recall
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Distribution Pattern
Distributed to 4 hospitals in the following states: NM, OH, TX, WV
Code Information
All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R