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Recall Observatory FDA recall evidence

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

October 26, 2018

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
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

    reason.labeling_packaging · v1.0.0

    packaging error

Field note

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