Z-0466-2021 Class II Ongoing
FDA device recall Z-0466-2021 was initiated by Coltene Whaledent Inc on October 20, 2020 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 556.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- October 20, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 556
Product Description
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Reason for Recall
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.
Distribution Pattern
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Code Information
J74027