PlainRecalls
FDA Devices Moderate Class II Terminated

RePlant¿ Angled Abutment Part Number 6050-52-60

Reported: August 10, 2016 Initiated: July 5, 2016 #Z-2320-2016

Product Description

RePlant¿ Angled Abutment Part Number 6050-52-60

Reason for Recall

Issue with design specification; oversized condition.

Details

Units Affected
205
Distribution
U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
Location
Westlake Village, CA

Frequently Asked Questions

What product was recalled?
RePlant¿ Angled Abutment Part Number 6050-52-60. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 205.
Why was this product recalled?
Issue with design specification; oversized condition.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2320-2016.