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U.S. Department of Health and Human Services

Class 2 Device Recall NonSterile and Sterile Procedural Trays

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  Class 2 Device Recall NonSterile and Sterile Procedural Trays see related information
Date Initiated by Firm November 17, 2022
Date Posted January 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-1034-2023
Recall Event ID 91387
Product Classification Orthopedic tray - Product Code OJH
Product Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Code Information Item Number: CDSOPP508AG, UDI/GTIN Case: 40195327145140, UDI/GTIN Each: 10195327145149, Lot Number: 22HBO323
Recalling Firm/
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
Manufacturer Reason
for Recall
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
FDA Determined
Cause 2
Device Design
Action Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.
Quantity in Commerce 45 units
Distribution US Nationwide distribution in the states of AR, MD, WA, WI.
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.