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U.S. Department of Health and Human Services

Class 3 Device Recall INTEGRA, Drill CS 4.5, quick coupling single use

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  Class 3 Device Recall INTEGRA, Drill CS 4.5, quick coupling single use see related information
Date Initiated by Firm January 25, 2019
Create Date December 22, 2019
Recall Status1 Open3, Classified
Recall Number Z-0731-2020
Recall Event ID 84383
Product Classification Bit, drill - Product Code HTW
Product INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Code Information Lot Code: QR0013
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
Action The firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use.
Quantity in Commerce 2 units
Distribution Texas
Total Product Life Cycle TPLC 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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