| | Class 2 Device Recall SINGLES Carbide USNo. FG556 |  |
| Date Initiated by Firm | July 15, 2020 |
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| Create Date | September 04, 2020 |
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| Recall Status1 |
Terminated 3 on February 24, 2022 |
| Recall Number | Z-2937-2020 |
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| Recall Event ID |
86147 |
| Product Classification |
Bur, dental - Product Code EJL
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| 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. |
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| Code Information |
LOT R50753 |
Recalling Firm/
Manufacturer |
Hager & Meisinger Gmbh
Hansemannstr. 10
Neuss Germany
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Manufacturer Reason
for Recall | US-dates between the product package label and the bar code display. |
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FDA Determined
Cause 2 | Process control |
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| Action | The US firm sent a recall letter to the affected consignees on 07/15/2020. On 07/23/2020 an UPDATED CUSTOMER NOTIFICATION - MEDICAL DEVICE RECALL letter with customer response form was sent to the consignees by US Mail. |
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| Quantity in Commerce | 144 units |
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| Distribution | US Nationwide distribution including in the states of AZ, CA, FL, IN, NY, PA and TX. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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