Z-0198-2022 Class II Ongoing

Recalled by Implant Direct Sybron Manufacturing LLC — Westlake Village, CA

Recall Details

Product Type
Devices
Report Date
November 10, 2021
Initiation Date
September 23, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
83 implants

Product Description

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Reason for Recall

Packaged dental implant contains a different size then the size declared on the labeling.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

Code Information

lot # 166300 / UDI: 10841307101796