PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 11, 2018 Initiated: May 18, 2018 #Z-2376-2018

Product Description

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

Details

Units Affected
60 units
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
Location
Thousand Oaks, CA

Frequently Asked Questions

What product was recalled?
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 60 units.
Why was this product recalled?
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Which agency issued this recall?
This recall was issued by the FDA Devices on July 11, 2018. Severity: Moderate. Recall number: Z-2376-2018.