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

• Date Initiated by Firm: March 21, 2023
• Date Posted: May 04, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1532-2023
• 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 ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
• Code Information: UDI-DI: 04026575044122 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: 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: 20 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