FDA recall Z-2376-2018

Implant Direct Sybron Manufacturing, LLC · Class II · device

Product

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

Reason for recall

Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

Distribution

CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland

Key facts

Status
Terminated
Initiation date
2018-05-18
Report date
2018-07-11
Termination date
2020-07-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Thousand Oaks, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2018