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Class 2 Device Recall LINK SymphoKnee System Distal Femoral Augment |
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Date Initiated by Firm |
December 23, 2022 |
Date Posted |
July 03, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2067-2023 |
Recall Event ID |
92496 |
510(K)Number |
K202924
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product |
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21 |
Code Information |
UDI-DI: 04026575257393
Lot Number: 2123233 |
Recalling Firm/ Manufacturer |
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
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For Additional Information Contact |
Same 494053995150
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Manufacturer Reason for Recall |
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
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FDA Determined Cause 2 |
Component change control |
Action |
LinkBio Corporation issued A Product Advisory Notice to consignees holding field inventory on 18-May-2023. The product is provided to the surgeon directly by the representative of the Distributor. Letter states reason for recall, health risk and action to take:
Please ensure the surgical team is made aware of this issue before using one of the affected augments. While there is no safety impact due to this issue, there could be some confusion during assembly if the issue is not known in advance. No additional action is required by users beyond reinserting the screw in the correct orientation, and no product return is required at this time.
Please contact your LinkBio Sales or Customer Service representative or the contact for any questions:
Jennifer Lubrecht
Senior Director, Quality Management
LinkBio Corporation
69 King Street
Dover, NJ 07801
Mobile: +1 862.477.0370 Email: j.lubrecht@LinkBio.com |
Quantity in Commerce |
20 units |
Distribution |
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX. |
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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