FDA Device recall Z-0018-2020
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile by Implant Direct Sybron Manufacturing, citing two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0018-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-08 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
Product
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reason
Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Identifiers
| code_info | Lot number 110350 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing
All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0018-2020%22
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