FDAFDA · Food and drugs·Recall number Z-0973-2013
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Published March 27, 2013 · Recall initiated: March 11, 2013
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
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Keystone Dental Inc
- Distributor
- Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
- Lot
- Lot Number: 12857
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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