FDA recall Z-0197-2022

Product

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Reason for recall

Packaged dental implant contains a different size then the size declared on the labeling.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

Key facts

Status

Ongoing

Initiation date

2021-09-23

Report date

2021-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2022