Recall Z-1917-2018 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgewo
| Date | Mar 14, 2018 |
| Status | Terminated |
| Reason | The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. |
| Root cause | Labeling mix-ups |
| Action | The recall letter dated 3/16/2018 was first issued via email to one of the foreign consignees on 3/14/2018. The U.S. and other foreign consignees were mailed letters on 3/16/2018 via FedEx overnight mail. the letter identified the affected product, problem and actions to be taken. |
| Quantity | 298 implants |
| Distribution | Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM Implant Direct Sybron Manufacturing, LLC, Dec 24, 2013 |