Class 2 Device Recall LINK SymphoKnee Modular Stem

• Date Initiated by Firm: February 14, 2025
• Date Posted: March 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1372-2025
• Recall Event ID: 96386
• 510(K)Number: K202924
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
• Code Information: Product Code: 880-601/11; UDI-DI: 04026575443925; Lot Numbers: 1943294, 1943296, 1943297, 2049174.
• Recalling Firm/ Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site); Oststr. 4-10; Norderstedt Germany
• For Additional Information Contact: Jennifer Lubrecht; 862-477-0370
• Manufacturer Reason for Recall: A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
• FDA Determined Cause: Labeling Change Control
• Action: On February 21, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the Customer/User: 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 37 units
• Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
• 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