Clinic Pack 100 Pieces FG 57 100057C (100057C)
Reported: November 25, 2020 Initiated: October 20, 2020 #Z-0466-2021
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.
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? ▼
Clinic Pack 100 Pieces FG 57 100057C (100057C). 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-0466-2021.
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