DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extensi
FDA device recall Z-0396-2016 · posted 2015-12-08 · Terminated
Recall details
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- 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.
- Action taken
- 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 any issues as a result of the affected products to report the incident to the FDA through he MEDWATCH reporting system.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 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
- Date initiated
- 2015-10-28
- Date posted
- 2015-12-08
- Date terminated
- 2016-04-08
- Location
- Westlake Village, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWISSPLANT DENTAL IMPLANT SYSTEM (K081396) | Implant Direct, LLC | 2009-01-14 |