FDA Device recall Z-1167-2018
SwishTapered Implant Intended for use in support for fixed bridgework
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of SwishTapered Implant Intended for use in support for fixed bridgework by Implant Direct Sybron Manufacturing, citing the extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1167-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-19 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | n/a |
Product
SwishTapered Implant Intended for use in support for fixed bridgework.
Reason
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Identifiers
| code_info | Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077). |
|---|
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
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-1167-2018%22
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