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.
This recall has been terminated (originally issued March 14, 2018).
- Recall Initiated
- March 14, 2018
- Terminated
- June 4, 2018
- Recall Number
- Z-1917-2018
- Quantity
- 298 implants
- Firm Location
- Thousand Oaks, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
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.
Lot / Code Info
Lot #68960
Root Cause
Labeling mix-ups
Action Taken
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.