FDAFDA · Food and drugs·Recall number Z-0467-2021
CEI Cutting Edge Instruments (PTC-57C)
Published November 25, 2020 · Recall initiated: October 20, 2020
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
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Coltene Whaledent Inc
- Distributor
- Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
- Lot
- J88954
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.