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U.S. Department of Health and Human Services

Class 2 Device Recall EndoModel Modular Knee Prosthesis System

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  Class 2 Device Recall EndoModel Modular Knee Prosthesis System see related information
Date Initiated by Firm March 18, 2021
Date Posted June 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-2047-2023
Recall Event ID 92500
510(K)Number K143179  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Code Information Item No. 15/2973/06; UDI-DI: 04026575340736.
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact
494053995150
Manufacturer Reason
for Recall		 The firm discovered through customer complaints that device segments may not meet specifications.
FDA Determined
Cause 2		 Device Design
Action The firm sent recall notifications by email to consignees on 03/24/2021. Customers were asked to discontinue use of affected devices and to return any that remain in stock to LinkBio Corporation, Waldemar Link's US Distributor, immediately. Credit or replacement was issued for the returned product upon receipt. Any questions about this recall event are to be directed to Nikhil Mangale at 1-973-625-1333 ext. 116 from Monday through Friday from 8:00 am to 5:30 pm, or by email to n.mangale@linkbio.com.
Quantity in Commerce 22 units
Distribution Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = KRO and Original Applicant = Waldemar Link GmbH & Co. KG
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