Recall Z-0396-2016 ยท NHA Abutment, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing, LLC
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.
| Date | Dec 8, 2015 (initiated Oct 28, 2015) |
| Status | Terminated |
| Reason | Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill. |
| Root cause | Unknown/Undetermined by firm |
| Action | On 10/28/15 customer notification letters were sent. Within the letter the firm states that if customers have any of the affected product listed to contact the firm's Customer Care at 1-888-649-6425. A return label is provided with notification. The firm states that if customers are an authorized Implant Direct Sybron Manufacturing distributor they request that they identify their customers that have been shipped the affected product, and contact them within 48 hours of receiving notification in order to obtain the product. The letter states if any customers or patients have experienced an |
| Quantity | 478 |
| Distribution | Worldwide Distribution- US (nationwide) including the states of CA, FL, TX, MO, MI, MA, NV, OR, PA, AZ, IL, VA, OH, GA, and SC, and the country of Canada, Poland, Serbia, Italy, Germany, Cairo, Jordan, El Salvador, Kuwait, Costa Rica, Switzerland, Colombia, United Kingdom, Austria, Netherlands, Chi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM Implant Direct, LLC, Jan 14, 2009 |