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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Total Knee Pack

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 Class 2 Device Recall Medline Total Knee Packsee related information
Date Initiated by FirmJune 10, 2026
Date PostedJuly 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2736-2026
Recall Event ID 99318
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Code Information UDI-DI 10198459538827 Kit Lots 26DMB644 26CMC467
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley 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 2		Under Investigation by firm
ActionOn 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 Commerce163 kits
DistributionUS Nationwide distribution in the states of CA and UT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LRO
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