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Class 2 Device Recall EndoModel Knee System |
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Date Initiated by Firm |
May 24, 2022 |
Create Date |
July 12, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1380-2022 |
Recall Event ID |
90477 |
510(K)Number |
K212742
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product |
Tibial Component Modular. orthopedic prosthesis. Model Nos:
Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
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Code Information |
UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741 |
Recalling Firm/ Manufacturer |
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
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For Additional Information Contact |
Jennifer Lubrecht 862-4770370
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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.
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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
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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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510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = Waldemar Link GmbH & Co. KG
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