FDAFDA · Food and drugs·Recall number Z-1321-2024
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Published March 27, 2024 · Recall initiated: February 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Preat Corp
- Distributor
- U.S. Nationwide distribution in the states of AZ, OH and PA.
- Lot
- Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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