FDAFDA · Food and drugs·Recall number Z-2529-2018
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.
Published August 1, 2018 · Recall initiated: March 16, 2018
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
The product label has missing information, such as the lot number and expiration date, as well as other information.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nobel Biocare Usa Llc
- Distributor
- Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland.
- Lot
- Lot #1270802
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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