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U.S. Department of Health and Human Services

Class 2 Device Recall Link EndoModel Patella Glide Resection Guide

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  Class 2 Device Recall Link EndoModel Patella Glide Resection Guide see related information
Date Initiated by Firm November 30, 2023
Date Posted January 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-0749-2024
Recall Event ID 93662
Product Classification Guide, surgical, instrument - Product Code FZX
Product Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure.
Product Code: 15-2530/05
Code Information UDI-DI :04026575245253 Lot / Serial Number: C306165
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		 Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
FDA Determined
Cause 2		 Under Investigation by firm
Action Link Bio Corp. issued Urgent Medical Device Recall Letter via email on 11/30/23. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of NH.
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.
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