FDAFDA · Food and drugs·Recall number 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 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.
Published October 29, 2014 · Recall initiated: September 19, 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
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Straumann USA, LLC
- Distributor
- US Distribution in states of: FL and MA.
- Lot
- Lot number: GY030 Exp. 2019-04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.