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U.S. Department of Health and Human Services

Class 3 Device Recall INTEGRA, Drill CS 4.0, quick coupling single use

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 Class 3 Device Recall INTEGRA, Drill CS 4.0, quick coupling single usesee related information
Date Initiated by FirmJanuary 25, 2019
Create DateDecember 22, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0732-2020
Recall Event ID 84383
Product Classification Bit, drill - Product Code HTW
ProductINTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Code Information Lot Code: QS0007
Recalling Firm/
Manufacturer		 AAP Implantate Ag
Lorenzweg 5
Berlin Germany
Manufacturer Reason
for Recall		Products were distributed with the incorrect instructions for use.
FDA Determined
Cause 2		Other
ActionThe firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use.
Quantity in Commerce7 units
DistributionTexas
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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