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U.S. Department of Health and Human Services

Class 2 Device Recall Brasseler

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 Class 2 Device Recall Brasselersee related information
Date Initiated by FirmJanuary 11, 2024
Date PostedFebruary 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1008-2024
Recall Event ID 93809
Product Classification Bur, dental - Product Code EJL
ProductBrasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Code Information Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Recalling Firm/
Manufacturer		 Brasseler USA I Lp
1 Brasseler Blvd
Savannah GA 31419-9576
For Additional Information ContactSally Ann Giles
800-841-4522 Ext. 5147
Manufacturer Reason
for Recall		The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe recalling firm issued letters dated 1/8/2024 on 1/11/2024 via certified mail. The letter explains the reason for recall and required customer actions. The actions included that upon receipt of the letter, confirm the quantity of unused recalled product in their inventory and set it aside for return. Return information will be emailed to the consignee with a return label. The Customer Service emailed the letters to consignees on 1/12/2024 and sent product return instructions in the email. Phone calls will be made on 1/16/2024 if no response if received from the consignee via email. The recalling firm will be recording the amount of product to be returned on the phone log which will be completed for every consignee contacted. During the call, the consignees will also be given the product return instructions.
Quantity in Commerce440 burs
DistributionWorldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.
Total Product Life CycleTPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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