FDA Device recall Z-0364-2020
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants by Implant Direct Sybron Manufacturing, citing A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0364-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-09 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | IN, MD, TX, VA, WA |
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
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Identifiers
| code_info | Lot #135128 Exp: 3/12/20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0364-2020%22
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