FG 57 100057X (100057X)
Reported: November 25, 2020 Initiated: October 20, 2020 #Z-0465-2021
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.
Details
- Recalling Firm
- Coltene Whaledent Inc
- Units Affected
- 556
- Distribution
- Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
- Location
- Cuyahoga Falls, OH
Frequently Asked Questions
What product was recalled? ▼
FG 57 100057X (100057X). Recalled by Coltene Whaledent Inc. Units affected: 556.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0465-2021.
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