FDAFDA · Food and drugs·Recall number Z-1061-2019
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
Published April 3, 2019 · Recall initiated: February 22, 2019
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
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Keystone Dental Inc
- Distributor
- FL, MA, SC, VA
- Lot
- Lot Numbers: WO-010252, WO-010136
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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