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Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on
Recalled October 9, 2019 · FDA recall Z-0010-2020 · Implant Direct Sybron Manufacturing
Hazard
The incorrect device was packaged in the vial. · FDA Class II
Units
158 devices
Sold at
Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
Description
The incorrect device was packaged in the vial.
Product
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →