FDA Device

XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant)

Hazard

Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.

What You Should Do

Remedy

Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.

Products

XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant)
Brand
Dentsply Friadent Ceramed
UPC
Model # 26-0122

Units Affected

1685 units