FDA-Device2018-07-11Class II
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Implant Direct Sybron Manufacturing, LLC
Hazard
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Sold states
CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
Affected count
60 units
Manufactured in
3050 E Hillcrest Dr, Thousand Oaks, CA, United States
Products
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief