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Implant Direct Sybron Manufacturing, LLC recalls Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only,
Recalled November 20, 2019 · FDA recall Z-0363-2020 · Implant Direct Sybron Manufacturing
Hazard
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. · FDA Class II
Units
53 implants
Sold at
US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Description
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Product
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →