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Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of sin
Recalled August 1, 2018 · FDA recall Z-2551-2018 · Implant Direct Sybron Manufacturing
Hazard
The main vial label lists the incorrect part number, but the cap label is correct. · FDA Class II
Units
124 units
Sold at
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.
Description
The main vial label lists the incorrect part number, but the cap label is correct.
Product
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.
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →