FDAFDA · Food and drugs·Recall number Z-0007-2018
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Published October 11, 2017 · Recall initiated: July 21, 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
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
- Lot
- Product Code 9048-13H, Lot No. 81080
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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