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…
- Recall date
- October 26, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0363-2020
- FDA classification
- Class II
- Brand / firm
- Implant Direct Sybron Manufacturing, LLC
- Sold / distributed
- US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Why it was recalled
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
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