Class 2 Device Recall Medline Total Knee Pack LF

• Date Initiated by Firm: June 10, 2026
• Date Posted: July 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2737-2026
• Recall Event ID: 99318
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
• Code Information: UDI-DI 10195327388447 Kit Lot 26DME172
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-633-5463
• Manufacturer Reason for Recall: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
• FDA Determined Cause: Under Investigation by firm
• Action: On June 10, 2026, the firm began notifying customers via First-Class Mail and email. Customers were instructed to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
• Quantity in Commerce: 163 kits
• Distribution: US Nationwide distribution in the states of CA and UT.
• 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.