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U.S. Department of Health and Human Services

Class 2 Device Recall Waldemar Link GmbH & Co.

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  Class 2 Device Recall Waldemar Link GmbH & Co. see related information
Date Initiated by Firm April 25, 2023
Date Posted June 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1674-2023
Recall Event ID 92294
510(K)Number K202924  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6
Tilastan, cemented.
Intended for primary and revision total knee replacement.
Item Number: 880-325/13
Code Information UDI-DI : 04026575258123 Lot Number: 1910003
Recalling Firm/
Manufacturer		 Linkbio Corp.
101 Round Hill Dr Ste 7
Rockaway NJ 07866-1214
For Additional Information Contact SAME
973-625-0766
Manufacturer Reason
for Recall		 Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
FDA Determined
Cause 2		 Under Investigation by firm
Action LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. 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 11 units
Distribution US Nationwide Distribution - AL, GA, IL, IN, LA, 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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