FDAFDA · Food and drugs·Recall number Z-1823-2017
Tapered SwissPlus Implant System, Model No. SPB10
Published April 26, 2017 · Recall initiated: March 20, 2017
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
It was manufactured with the minor diameter of the internal thread that is below specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Dental Inc
- Distributor
- Worldwide: ZA, FR, IT, IR
- Lot
- Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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