Z-0465-2021 Class II Ongoing
FDA device recall Z-0465-2021 was initiated by Coltene Whaledent Inc on Oct 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
- Nov 25, 2020
- Initiation Date
- Oct 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 556
Product Description
FG 57 100057X (100057X)
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
J79552
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0465-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026