Recall Z-0468-2021— Coltene Whaledent Inc
Class II · Ongoing
Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2020-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Strauss 25 Carbide Dental Burs (100057XXV). Reason: 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..
- Recalling firm
- Coltene Whaledent Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-10-20
- Firm location
- Cuyahoga Falls, OH, United States
Product description
Strauss 25 Carbide Dental Burs (100057XXV)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.