Z-0364-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- August 9, 2019
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 implants
Product Description
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 Pattern
U.S.: IN, VA, MD, TX, WA OUS: Japan
Code Information
Lot #135128 Exp: 3/12/20