FDA recall Z-1041-2020

Implant Direct Sybron Manufacturing LLC · Class II · device

Product

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Reason for recall

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

Distribution

U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP

Key facts

Status
Terminated
Initiation date
2019-10-07
Report date
2020-02-12
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2020