FDAFDA · Food and drugs·Recall number Z-0961-2017
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Published January 18, 2017 · Recall initiated: November 28, 2016
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
Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
- Lot
- Lot #75808
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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