FDA recall Z-0364-2020

Implant Direct Sybron Manufacturing, LLC · Class II · device

Product

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Reason for recall

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

Distribution

U.S.: IN, VA, MD, TX, WA OUS: Japan

Key facts

Status
Terminated
Initiation date
2019-08-09
Report date
2019-11-20
Termination date
2021-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0364-2020