FDA Device recall Z-0117-2015
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for…
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for… by Straumann Usa, citing assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-19 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Straumann Usa |
| Distribution | FL, MA |
Product
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.
Reason
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Identifiers
| code_info | Lot number: GY030 Exp. 2019-04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2015%22
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