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U.S. Department of Health and Human Services

Class 2 Device Recall LINK SymphoKnee System Distal Femoral Augment

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  Class 2 Device Recall LINK SymphoKnee System Distal Femoral Augment see related information
Date Initiated by Firm December 23, 2022
Date Posted July 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-2066-2023
Recall Event ID 92496
510(K)Number K202924  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients.
Product Code: 880-307/11
Code Information UDI-DI: 04026575257379 Lot Number: 2123225
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact Same
494053995150
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).
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
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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