FDAFDA · Food and drugs·Recall number Z-1835-2017
INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
Published April 26, 2017 · Recall initiated: February 22, 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
Incorrect device was packaged.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ace Surgical Supply Co., Inc.
- Distributor
- Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
- Lot
- Lot Number: 16100050
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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