FDA recall Z-0363-2020

Implant Direct Sybron Manufacturing, LLC · Class II · 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

Reason for recall

packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

Distribution

US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,

Key facts

Status
Terminated
Initiation date
2018-10-26
Report date
2019-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0363-2020