Z-1917-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- March 14, 2018
- Termination Date
- June 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 298 implants
Product Description
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.
Reason for Recall
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
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.
Code Information
Lot #68960