Recall Z-0396-2016— Implant Direct Sybron Manufacturing, LLC
Class II · Terminated
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2015-10-28, terminated 2016-04-08. It names one FDA 510(k) clearance: K081396. Product: DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.. Reason: Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-28
- Terminated
- 2016-04-08
- Firm location
- Westlake Village, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.
Reason for recall
Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.
Data sourced from openFDA. This site is unofficial and independent of the FDA.