Device product
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 bridgework.
Z-1917-2018
Product summary
- Event
- Event 79793
- Status
- Terminated
- Classification
- Class II
- Quantity
- 298 implants
- Official record key
device-enforcement:Z-1917-2018
Official wording
Reason: The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Code information: Lot #68960
Distribution pattern: 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.
Derived failure modes
-
Unknown
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.