FDAFDA · Food and drugs·Recall number Z-0174-2015
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
Published November 12, 2014 · Recall initiated: September 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Straumann USA, LLC
- Distributor
- US Nationwide Distribution
- Lot
- Lot number: GY256
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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