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U.S. Department of Health and Human Services

Class 2 Device Recall Soft tissue retractor, radiolucent

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  Class 2 Device Recall Soft tissue retractor, radiolucent see related information
Date Initiated by Firm November 28, 2019
Create Date April 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-1675-2020
Recall Event ID 84716
Product Classification Retractor - Product Code GAD
Product aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Code Information Lot Numbers: I012, I025, I028
Recalling Firm/
Manufacturer		 AAP Implantate Ag
Lorenzweg 5
Berlin Germany
Manufacturer Reason
for Recall		 The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
FDA Determined
Cause 2		 Use error
Action The firm initiated the recall by email on 11/28/2019. The letter explained the reason for recall and requested the following: "Please take the following actions immediately: 1. Please immediately remove all products with the catalog number in question from your warehouse or from affected trays to prevent further use. 2. A confirmation form is enclosed with this letter; please fill in, sign it and return it to us after receiving this information. If you have no affected products, please fill in the confirmation form anyway and fax it to 0049 (0) 30 750 19 111 or email it to incident@aap.de. 3. Please immediately return any products you still have in stock to us. Please ensure that all users of the affected products within your organization and other persons who are affected receive this information via the Field Safety Notice. If products are passed on to third parties, please also send these third parties a copy of the Field Safety Notice or inform our contact. "
Quantity in Commerce 7 units
Distribution Worldwide Distribution
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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