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
Z-0364-2020
Product summary
- Event
- Event 83763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 implants
- Official record key
device-enforcement:Z-0364-2020
Official wording
Reason: A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Code information: Lot #135128 Exp: 3/12/20
Distribution pattern: U.S.: IN, VA, MD, TX, WA OUS: Japan
Derived failure modes
-
Unknown
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.