Device 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
Z-0363-2020
Product summary
- Event
- Event 83794
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 implants
- Official record key
device-enforcement:Z-0363-2020
Official wording
Reason: packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Code information: Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023
Distribution pattern: US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Derived failure modes
-
Labeling or packaging
packaging error