FDAFDA · Food and drugs·Recall number Z-0363-2020
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Published November 20, 2019 · Recall initiated: October 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
- Lot
- Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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