FDA-Device2019-10-09Class II
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.
Implant Direct Sybron Manufacturing, LLC
Hazard
The incorrect device was packaged in the vial.
Sold states
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.
Affected count
158 devices
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2020Don't want to check this manually?
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