FDA Device recall Z-1917-2018
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile by Implant Direct Sybron Manufacturing, citing the cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1917-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-14 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
Product
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: 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 cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Identifiers
| code_info | Lot #68960 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2025-08-06 · Implant Direct Sybron Manufacturing - LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE
FDA Device · Class II · 2023-07-05 · Implant Direct Sybron Manufacturing - ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform
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
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All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1917-2018%22
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