Z-2551-2018 Class II Terminated
FDA device recall Z-2551-2018 was initiated by Implant Direct Sybron Manufacturing, LLC on March 3, 2017 and is designated Class II. Reason for recall: The main vial label lists the incorrect part number, but the cap label is correct. The recall status is terminated (terminated August 6, 2018). Affected quantity: 124 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- March 3, 2017
- Termination Date
- August 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 units
Product Description
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.
Reason for Recall
The main vial label lists the incorrect part number, but the cap label is correct.
Distribution Pattern
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.
Code Information
Lot #87837