Recall Z-2937-2020— Hager & Meisinger Gmbh
Class II · Terminated
Class II FDA medical device recall by Hager & Meisinger Gmbh, initiated 2020-07-15, terminated 2022-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.. Reason: US-dates between the product package label and the bar code display..
- Recalling firm
- Hager & Meisinger Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-15
- Terminated
- 2022-02-24
- Firm location
- Neuss, Germany
Product description
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
Reason for recall
US-dates between the product package label and the bar code display.
Data sourced from openFDA. This site is unofficial and independent of the FDA.