ImplantDirect, 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 3, 2017).
- Recall Initiated
- March 3, 2017
- Terminated
- August 6, 2018
- Recall Number
- Z-2551-2018
- Quantity
- 124 units
- Firm Location
- Thousand Oaks, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The main vial label lists the incorrect part number, but the cap label is correct.
Distribution
Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
Lot / Code Info
Lot #87837
Root Cause
Process control
Action Taken
Recall notifications dated 2/13/2017 were issued to U.S. consignees via UPS overnight on 3/3/2017. Foreign consignees received letters on 3/13/2017 and 3/14/2017.
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