FDA Device recall Z-2551-2018
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-uni…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-uni… by Implant Direct Sybron Manufacturing, citing the main vial label lists the incorrect part number, but the cap label is correct.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2551-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-03 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, WA |
Product
ImplantDirect, Dental implants 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
The main vial label lists the incorrect part number, but the cap label is correct.
Identifiers
| code_info | Lot #87837 |
|---|
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-2551-2018%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.