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U.S. Department of Health and Human Services

Class 2 Device Recall Adapter for handpiece, one piece

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 Class 2 Device Recall Adapter for handpiece, one piecesee related information
Date Initiated by FirmApril 03, 2019
Create DateMay 22, 2019
Recall Status1 Terminated 3 on August 12, 2019
Recall NumberZ-1390-2019
Recall Event ID 82675
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductAdapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
Code Information Lot number:17415 UDI: 07640182640705
Recalling Firm/
Manufacturer		 Thommen Medical AG
Eschenweg 3
Bettlach Switzerland
Manufacturer Reason
for Recall		Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
FDA Determined
Cause 2		Under Investigation by firm
ActionThommen Medical AG notified the account on 3/27/19 via email asked distributors to put any adapters in their stock in quarantine. Furthermore recall all adapters shipped to their customers. All recovered adapters to be sent back to Thommen Medical AG, who will supply them with new adapters which conform to the specifications.
Quantity in Commerce15 US
DistributionUS Nationwide distribution in the state of OH.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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