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U.S. Department of Health and Human Services

Class 2 Device Recall Lambotte chisel

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  Class 2 Device Recall Lambotte chisel see related information
Date Initiated by Firm January 11, 2019
Create Date March 18, 2019
Recall Status1 Terminated 3 on May 26, 2022
Recall Number Z-1019-2019
Recall Event ID 82159
Product Classification Chisel (osteotome) - Product Code KDG
Product aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20

Product Usage:
Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
Code Information Lot Numbers: I011, I012, I013, I014, I015, I016, I017
Recalling Firm/
Manufacturer		 AAP Implantate Ag
Lorenzweg 5
Berlin Germany
Manufacturer Reason
for Recall		 There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
FDA Determined
Cause 2		 Process design
Action The firm initiated the recall on 01/11/2019 by email and fax. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Please immediately remove all products/articles of the affected lot numbers from your stock to secure any further use. 2. With this letter you will receive a confirmation form, please complete it completely, sign it and send it back to us immediately after receiving this information. If you do not have any affected products, please fill out the confirmation form and fax lt to 0049 (0) 30 750 19 111 or mail it to incident@aap.de. 3. Please return all affected products/articles immediately to us.
Quantity in Commerce 25 units
Distribution Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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