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U.S. Department of Health and Human Services

Class 2 Device Recall EndoModel Knee System

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  Class 2 Device Recall EndoModel Knee System see related information
Date Initiated by Firm May 24, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1377-2022
Recall Event ID 90477
510(K)Number K212742  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Code Information UDI-DI  04026575316281 (Small) 04026575316298 (Medium) 04026575316304 (Large)  Serial/Lot Numbers: 210420/0762 210426/0311 210426/0363 210426/0364 210426/0374 210504/2485 210504/2552 210504/2564 210504/2566 210510/2845 210510/2846 210602/0215 210602/0265 210602/0266 210602/1068 210602/2717 210602/2721 210602/2733 210602/2769 210629/0893 210629/0919 210629/0929 210629/0967 210629/0969 210629/1046 210629/1051 210629/1054 210629/2750 210802/0663 210802/0771 210802/0841 210907/2316 210907/2317 210913/0613 210913/0622 210913/0762 210913/0797 210913/0801 210913/0809 210913/2167 211025/0391 211025/2541 211025/2543 211025/2563 211102/0426 211102/0431 211115/0220 211115/1948 211115/2111  
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact Jennifer Lubrecht
862-4770370
Manufacturer Reason
for Recall		 There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On May 24, 2022, the firm notified affected customers via Urgent Field Safety Notice email. Customers were provided a modified surgical technique providing information for the cementing technique for Tilastan proximal spacers to minimize the risk. No product return is required.
Quantity in Commerce 3785
Distribution Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
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 = JWH and Original Applicant = Waldemar Link GmbH & Co. KG
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