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U.S. Department of Health and Human Services

Class 2 Device Recall LINK SLED Knee System and LINK SLED Knee System with PorEx (TiNbN) coating

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  Class 2 Device Recall LINK SLED Knee System and LINK SLED Knee System with PorEx (TiNbN) coating see related information
Date Initiated by Firm March 21, 2023
Date Posted May 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-1515-2023
Recall Event ID 92088
510(K)Number K954186  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 50MM

Item Number: 15-2028/05
Code Information UDI-DI: 04026575043972 All lot numbers within the labeled expiration date
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
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
FDA Determined
Cause 2
Labeling design
Action LinkBio issued Urgent Medical Device Correction letter on March 21, 2023 to US Distributors. Letter states reason for recall, health risk and action to take: Please take note of the amendment / reinforcement of the Surgical Technique and participate in future offering of product training on the updated technique. Two warnings have been added. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Attendance in future product training on the LINK SLED is required for continued use of the system. No action is required for devices which have already been implanted; continue with regular follow-up activities for patients who have received the LINK SLED knee system. All product lots of the above item numbers still within the labeled expiration date are in scope for this device correction. Waldemar Link GmbH & Co. KG is updating the surgical technique to incorporate the new warnings. The company will also be providing product training, through the LinkBio Medical Education team. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Quantity in Commerce 19 units
Distribution NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus
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 = HSX and Original Applicant = LINK AMERICA, INC.
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