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Straumann USA, LLC recalls Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental imp
Recalled October 29, 2014 · FDA recall Z-0117-2015 · Straumann USA
Hazard
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) · FDA Class II
Units
6 units
Sold at
US Distribution in states of: FL and MA.
Description
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
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.
Manufacturer(s)
Straumann USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →