FDA Device recall Z-0089-2019
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform
- FDA Device
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform by Implant Direct Sybron Manufacturing, citing cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0089-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-29 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
Product
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Reason
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Identifiers
| code_info | Part number 8735-05, Lot number 90212 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0089-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.