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Straumann USA, LLC recalls Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Den
Recalled November 12, 2014 · FDA recall Z-0174-2015 · Straumann USA
Hazard
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) · FDA Class II
Units
111 units
Sold at
US Nationwide Distribution
Description
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Product
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: 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. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
Manufacturer(s)
Straumann USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →