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Terminated

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

FDA Recall Z-0620-2018 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeHBE
Date Initiated2017-09-05
Date Terminated2019-09-20
Product Quantity6211

Reason for Recall

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

Firm Action

Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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